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

Model Number	S-60-080-120-P6
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional ht steelcore 18 device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that this was a procedure to treat a lesion in the superficial femoral artery with heavy calcification.An ht steelcore 18 guide wire was advanced to the target lesion, and pre-dilatation was successfully performed.Then two unspecified supera stents were deployed.A third supera self-expanding stent delivery system (sess) was advanced to the target lesion, and the stent was deployed.However, during removal of the sess, the delivery system was stuck to the guide wire and wire access was lost.Both, the sess and guide wire were removed as a single unit.The procedure ended at this point.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 returned.Visual and functional analysis was performed on the returned device.The reported difficulty removing the supera from the steelcore guide wire was confirmed.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 complaints reported from this lot.The investigation determined, that the difficulties were likely related to procedural circumstances.It was reported, that two unspecified supera stents were advanced, deployed and removed from the steelcore guide wire with no difficulties.And after advancing the third supera device and deploying the stent, difficulty was encountered, during removal.This suggests that the wire was likely, damaged (kinks/bends) as noted, on the returned unit.Causing the supera to become frozen to the wire, resulting in the inability to remove.There is no indication, of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 11604581
• Report Number: 2024168-2021-02637
• Device Sequence Number: 14252139
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 08/31/2022
• Device Model Number: S-60-080-120-P6
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 0090161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3 IMPLANTED SUPERA STENTS; HT STEELCORE 18, LT J 300 GUIDE WIRE
• Patient Age: 79 YR
• Patient Weight: 97