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

Model Number	S-60-150-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
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.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after stent deployment during removal of the device the tip inadvertently got caught on the deployed stent resulting in the reported difficult to remove.Manipulation of the compromised device resulted in the reported stretched stent and ultimately resulted in the reported tip material separation; thus resulting in the reported poor flow (obstruction/ occlusion).The treatment appears to be related to the operational context of the procedure as the patient was sent to surgery for a cut down to remove the tip and then a femoral/popliteal bypass was performed to treat the target lesion.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.
Event or Problem Description
It was reported that the procedure was to treat the left superficial femoral artery (sfa) with no calcification or tortuosity.The 6x150 mm supera self expanding stent system (sess) deployed the stent and there was poor flow after deployment.During removal of the delivery system there was some resistance and the stent elongated but remains in the target lesion.It was found that the tip of the delivery system detached after deployment.The patient was sent to surgery for a cut down to remove the tip and then a femoral/popliteal bypass was performed to treat the target lesion.The patient is doing fine now.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, medwatch mw5166803 was received which states: unraveling of supera stent with retain hardware in the subcutaneous tissue/intra-arterial.The stent was deployed in the usual fashion, unfortunately the distal end could not be freed as a result the stent unraveled and the most proximal end fully deploying in the sheath.
Additional Manufacturer Narrative
A4: corrected weight from 90 kg to 93 kg.E3: corrected occupation from na to physician.

• 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: 21425973
• Report Number: 2024168-2025-01932
• Device Sequence Number: 20774367
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: (01)08717648211843(17)260831(10)4090961
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 08/31/2026
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 4090961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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; Disability
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White