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

Model Number	S-50-120-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the common iliac artery with a 5mm diameter.After pre-dilatation was performed using three unknown balloon catheters sized at 3mm, 4mm and 5mm, a 5.0x120mm supera self-expanding stent (ses) was advanced to the lesion, over a.018" guidewire and through a 7f sheath, and attempted to be deployed; however, during deployment it was noted that the stent was unable to be fully released.The supera stent was noted to be deployed slightly in the introducer sheath and was removed under fluoroscopy, and replaced with a non-abbott device and the procedure was completed.There were no adverse patient effects nor clinical delay.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.
Additional Manufacturer Narrative
The device was returned for analysis and the stent was identified to be separated.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.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 similar 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 during stent deployment the sheath was too close and the stent inadvertently deployed into the sheath resulting in the reported activation failure.Manipulation of the compromised device resulted in the noted kinked inner member.After withdrawal, manipulation of the stent during removal from the sheath resulted in the noted stent stretched/bent/smashed braids and ultimately resulted in the noted stent separation.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.B5 - describe event or problem updated.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the common iliac artery with a 5mm diameter.After pre-dilatation was performed using three unknown balloon catheters sized at 3mm, 4mm and 5mm, a 5.0x120mm supera self-expanding stent (ses) was advanced to the lesion, over a.018" guidewire and through a 7f sheath, and attempted to be deployed; however, during deployment it was noted that the stent was unable to be fully released.The supera stent was noted to be deployed slightly in the introducer sheath and was removed under fluoroscopy, and replaced with a non-abbott device and the procedure was completed.There were no adverse patient effects nor clinical delay.Subsequent to the initially filed report the device was received and the analysis revealed that the stent was completely deployed and there was a separation of the stent at 10cm (centimeters) proximally from distal end of stent.It was confirmed by the account that the additional damages noted in the analysis occurred post-procedure as the physician was noted to further inspect the device, after its removal, to ensure that all parts were removed.No additional information was provided.

• 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: 21516767
• Report Number: 2024168-2025-02291
• Device Sequence Number: 15537407
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: (01)08717648211775(17)250831(10)3091961
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 08/31/2025
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 3091961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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: GUIDEWIRE: V18 FROM BTK ,0.018,300CM.; SHEATH: 7F
• Patient Sex: Unknown