Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Contour VL Variable Length Ureteral Stent. Details of the affected products are as follows:
| Product | Model number | Lot/Batch number | Range of Expiration Date |
|---|---|---|---|
| Contour VL Stent | M0061801550 | 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349 | 28 Feb 23 through 6 Aug 23 |
| M0061801560 | 25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104 | 28 Feb 23 through 6 Aug 23 | |
| M0061801570 | 25578740, 25583824 | 28 Feb 23 through 6 Aug 23 | |
| Contour VL Stent Kit | M006180155090 | 25928323, 25928324 | 28 Feb 23 through 6 Aug 23 |
| M006180156090 | 25928325, 25928326, 25933063, 25933064, 25933065 | 28 Feb 23 through 6 Aug 23 | |
| M006180156180 | 25965814 | 28 Feb 23 through 6 Aug 23 | |
| M006180156190 | 25966020 | 28 Feb 23 through 6 Aug 23 |
The manufacturer is implementing a product removal of unused affected products due to trace amounts of metallic debris found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel from the surface coating of one of the manufacturing fixtures used to form the stents. No complaints have been received to date by the manufacturer for this issue.
The manufacturer assessed the potential health consequences of trace amounts of metallic debris found on stents and concluded that no adverse health consequences are expected to occur considering the quantity and size of the particles that may be present. According to manufacturer, it is most likely that any particles released from the stent into the patient would be flushed out of the patient during urination without injury. The most severe potential injury that could occur would be stone formation, resulting from a particle being retained in the patient. However, the likelihood of this occurrence is remote. Therefore, proactive measures for patients with previously implanted stents is not recommended.
The removal notification only pertains to the unused affected products. The manufacturer requests the customers to verify whether any product from the affected lots/batches is within their inventory by using the above information provided. Further distribution or use of any remaining unused affected products from the affected lots/batches should cease immediately.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 19 November 2020