MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-65-060-120-P6
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2024, the patient had a 6.5x60mm supera self-expanding stent implanted in the popliteal artery.The patient had an angiogram performed on (b)(6) 2024, as the patient was experience back pain.It was noted that the supera stent appeared to be fractured and twisted.Over the counter pain medication was given.The patient was seen by vascular surgery and will be proceeding with a bypass.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) 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.The investigation determined a conclusive cause for the reported deformation due to compressive stress and the reported stent break 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.H6 correction: health effect - clinical code 1994 removed; health effect - impact code 4614 removed.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20453278
• Report Number: 2024168-2024-12142
• Device Sequence Number: 18449648
• Product Code: NIP
• UDI-Device Identifier: 08717648226243
• UDI-Public: (01)08717648226243(17)240831(10)2091461
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 11/08/2024

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: 08/31/2024
• Device Model Number: S-65-060-120-P6
• Device Catalogue Number: S-65-060-120-P6
• Device Lot Number: 2091461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2022
• 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: Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 79 KG