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

Model Number S-60-100-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2022

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a lesion in the superficial femoral artery with a 6mm vessel diameter.Following pre-dilatation, the 6.0x100mm supera self-expanding stent system (sess) was advanced without issues and the stent was fully deployed; however, the unlock was not working and the stent would not detach from the device.The sess and stent were pulled back under fluoroscopy, but resistance with the anatomy was felt.Additionally, the nose cone separated and the stent was deployed in healthy tissue.The nose cone was successfully snared.There was no clinically significant delay in the procedure.

Manufacturer Narrative

The device was not returned for analysis.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 similar incidents from this lot.It is possible that interactions with the anatomy resulted in the ratchet being unable to properly engage and fully release the stent from the delivery system resulting in the reported physical resistance/sticking and the reported difficult or delayed activation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported physical resistance/sticking and the reported difficult or delayed activation cannot be determined.During removal resistance/interaction with the anatomy likely resulted in the reported difficult to remove and ultimately resulted in the reported material separation.The treatment appears to be related to the operational context of the procedure as the stent was deployed in healthy tissue and the nose cone was successfully snared.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15077716
• MDR Text Key: 296334388
• Report Number: 2024168-2022-08008
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: 08717648211829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: S-60-100-120-P6
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 0111161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SHEATH: 6FR 10CM
• Patient Outcome(s): Required Intervention