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

Catalog Number	S-60-150-120-P6
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa) with moderate calcification, no tortuosity and 90% stenosis.A 6.0x150mm 120cm supera self-expanding stent system (sess) was advanced over a non-abbott 0.014 guide wire (gw) to the target site.The supera stent was deployed at the intended site without issue.During withdrawal of the delivery catheter, resistance was felt with the gw, thus both were removed from the anatomy intact as one unit which caused loss of access.A new access site was established, and a second 5.5x150 120cm supera sess was advanced over a new non-abbott 0.014 gw to the intended target site.The stent was deployed without issue.Again during withdrawal, the delivery system felt resistance with the gw and both were removed from the anatomy as one unit, intact.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that interactions with the moderately calcified and 90% stenosed anatomy and/or a coagulation of blood and contrast on the guide wire resulted in the reported difficult to remove; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional supera device(s) referenced in b5 is/are filed under separate medwatch report number(s).

• 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
• 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: 19137640
• Report Number: 2024168-2024-04835
• Device Sequence Number: 9402387
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: (01)08717648211843(17)250630(10)3072461
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: 06/30/2025
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 3072461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI PROWATER 0.014 GUIDE WIRE (GW) X2
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 80 KG