EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Recall
- Recall Number
- Z-1644-2022
- Event Number
- 90652
- Firm
- Medtronic Inc.
- FEI Number
- 2183870
- Product Code
- NIP
- Status
- Open, Classified
- Root Cause
- Other
- Initiated
- July 14, 2022
- Address
- 4600 Nathan Ln N, Plymouth, MN, 55442-2890
Description
EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
In the United States (US) on 14-Jul-2022, a written Medical Device Correction letter was mailed via 2-day tracked delivery to all consignees who have received affected product according to Medtronic Records. Outside the United States (OUS), beginning on 14-Jul-2022 a written Medical Device Correction letter was delivered to consignees who have received potentially affected product according to Medtronic records via regionally approved methods. For both US and OUS customers the letter notified customers of the correction (IFU update), provided a video link that demonstrates the updated procedure, and provided customers a summary of reported complaints and potential harms. The letter states the following: In the unlikely event of a delivery system failure, where the stent is partially deployed and the thumbwheel is unable to rotate, the following steps may solve the issue to successfully deploy the stent: 1. Ensure that the safety locking pin is completely removed from the delivery system, and there is no slack in the system. 2. Separate the gray strain relief from the handle using an 11-blade scalpel to cut the gray strain relief on the top and bottom of the handle. Cut from the white tabs toward the handle. See Figure 1and Figure 2. Note: Do not cut beyond the white tabs. Cutting beyond the white tabs may cut into the catheter, causing damage to the catheter. 3. Use a hemostat to slide the strain relief down the catheter and away from the handle. See Figure 1and Figure 2. Caution: Failure to hold the delivery system in a fixed position may cause the stent to foreshorten or lengthen. 4. Locate the seam that runs along the length of the handle. Open the two halves of the handle by separating the halves at the open safety locking pin location. Use a hemostat if necessary. 5. Set aside the two halves of the handle. 6. Keep the inner shaft and delivery system stable. 7. Hold the gold isolation sheath with one hand, and use the other hand or a hemostat, to grip the cable
worldwide
183964 devices