MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-50-080-120-P6
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a 70% stenosed and moderately calcified de novo lesion in the right popliteal artery.The non-abbott embolic protection filter wire was unable to be removed from the 5.0x80mm supera self-expanding stent system (sess) after deployment.The stent delivery system and the wire were removed as one unit.There was no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported difficulty removing the supera from the guide wire was able to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints.The investigation was unable to determine a cause for the reported difficulties.It may be possible that during removal of the supera delivery system post stent deployment, the clearance between the guide wire lumen of the supera and outer surface of the guide wire became reduced due to anatomical conditions resulting in the devices becoming frozen together.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10580855
• Report Number: 2024168-2020-07981
• Device Sequence Number: 13757692
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• Combination Product (Y/N): N
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 0011561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EMBOLIC PROTECTION DEVICE: 6 MM SPIDER FILTER WIRE; EMBOLIC PROTECTION DEVICE: 6 MM SPIDER FILTER WIRE
• Patient Age: 52 YR