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

Model Number S-45-040-120-P6

Device Problems Product Quality Problem (1506); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported product quality problem irregular appearance and the reported material separation were 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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during unpackaging and/or during preparation for use resulted in the reported tip separation/noted tip jacket and inner member separations; thus resulting in the reported product quality problem irregular appearance.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional supera self expanding stent referenced in report is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat the popliteal and distal femoral artery (sfa) via a direct stick to the popliteal through a bypass graft.The vessel diameter was 4-4.5mm, and the atherectomy was not used.During preparation of a 4.5x40mm supera self expanding stent (sses) the nosecone appearance did not like how it looked therefore was not used in the patient.Another 4.5x60mm supera sses was prepared, and the vessel was prepared with a balloon dilatation.The stent was deployed; and during removal under fluoroscopy, the red levers were not locked before the catheter was being pulled out, the nosecone got stuck on the stent strut and then detached.The nosecone was unable to be removed from the location.The delivery system was removed under fluoroscopy.The nosecone remains in the peroneal artery; however, the artery was confirmed to be patent.There were no reported adverse patient sequela.Returned device analysis of the 4.5x40 supera sess identified a separated tip which was not returned.The account stated it was likely discarded.No additional information was provided.

• 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: 16444222
• MDR Text Key: 310290818
• Report Number: 2024168-2023-01949
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648225925
• UDI-Public: 08717648225925
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-45-040-120-P6
• Device Catalogue Number: S-45-040-120-P6
• Device Lot Number: 2102861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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
• Patient Sex: Male