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	Stretched (1601); Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	11/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 reported patient effects of occlusion and surgical procedure are listed in the supera instructions for use as known potential patient effects associated with peripheral percutaneous intervention.Based on the information provided, a definitive cause for the reported difficulties and subsequent patient effects could not be determined.It may be possible that the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to properly engage the stent resulting in deployment difficulty; however, this could not be confirmed.The stent stretching and migration was likely the result of pulling back the delivery system with the stent still attached to the delivery system.The surgical procedure, additional treatment and hospitalization were related to circumstances of the procedure.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 a lesion located in the left external iliac that was heavily calcified.A supera 5.5 was deployed without issue.A second supera was advanced to the lesion and deployed, but during removal of the stent delivery system, the stent was dragged and stretched over the bifurcation, resulting in no blood flow or pulses to the lower extremity.Two stents were implanted as treatment to open the vessels.On (b)(6) 2020, surgical bypass was successfully performed.No additional information was provided.

• 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: 11032520
• Report Number: 2024168-2020-10676
• Device Sequence Number: 1046711
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: 08717648211799
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: 10/31/2021
• Device Model Number: S-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 9110461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability