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

Model Number	S-60-040-120-P6
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through a research article that the procedure was performed to treat an occlusion in an arteriovenous graft (avg) of a tortuous part of the elbow.A kink was noted in the previous unspecified implanted stent.The supera self expanding stent system (sess) was advanced, and the stent was deployed.The artificial dialysis was drained which caused a drop in blood pressure.This resulted in acute occlusion.Percutaneous transluminal angioplasty (pta) was performed and the patient recovered.It was noted that placement of the supera stent is somewhat difficult to position due to the resilience of the stent.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3, b6, d6a: dates estimated.H6: medical device problem code 1494 - incorrect anatomy.
Additional 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 incidents from this lot.It is possible that the reported difficult to advance was due to the reported kinked stent graft at the tortuous part of elbow; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficult to advance cannot be determined.Additionally, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.The reported patient effect(s) of occlusion and hypotension is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.There is no indication of a product quality issue with respect to manufacture, design or labeling.B1 - adverse event/product problem: "product problem" was added.

• 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: 16786388
• Report Number: 2024168-2023-04158
• Device Sequence Number: 17501801
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: 08717648211799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: S-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 0021261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male