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

Model Number	S-60-060-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
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.
Event or Problem Description
It was reported this was a procedure to treat the distal left superior femoral artery.A 6.0x60 supera stent was inserted and advanced to the target lesion.However, during advancement, the stent interacted with a previously implanted stent, causing the stent to elongate roughly 20mm.The stent was still able to be deployed at the target lesion without issues.No adverse patient effects occurred and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.However, the stent component was not returned as it remains in the patient anatomy.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 found that there is not a lot specific product quality issue.The investigation determined that operational context was the likely cause for the reported elongation and difficulty advancing the supera device.It is likely the supera stent was deployed such that there was an overlap both at the distal and proximal ends with previously implanted stents, both of which the inner diameter was not reported.Once recognized that elongation was occurring the user appears to have mitigated the elongation by manipulating the stent pattern, or ¿stacking¿ of the stent during deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 11455635
• Report Number: 2024168-2021-01911
• Device Sequence Number: 11710090
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: 08717648211805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/09/2021

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: 04/30/2022
• Device Model Number: S-60-060-120-P6
• Device Catalogue Number: S-60-060-120-P6
• Device Lot Number: 0050761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 110