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 Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a 100%, heavily calcified and chronic totally occluded (cto), lesion.The vessel diameter was 6.0mm and the lesion length was 100mm.A 6f 45cm sheath was advanced and the lesion was pre-dilatation with an unspecified balloon dilatation catheter.A 6.0x40mm supera self-expanding stent system (sess) was to be implanted at the distal part of the lesion and a non-abbott stent at the proximal part of the lesion.The sess was advanced and on attempting to deploy the stent, the user inadvertently pulled the sess back after 1cm had deployed and the stent jumped.The supera sess was removed under fluoroscopy with the stent partially deployed.The non-abbott stent was implanted at the proximal to distal part of lesion were the supera was planned to be implanted, successfully completing the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.It may be possible that the distal shaft was entrapped or restricted in the anatomy such that the ratchet was unable to properly engage the stent to fully deploy; however, this could not be 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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported difficulties.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: 10554644
• Report Number: 2024168-2020-07834
• Device Sequence Number: 19715051
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: 08717648211799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 02/28/2021
• Device Model Number: S-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 9031161
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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: GUIDE CATHETER, PARENT 6FR,; GUIDE WIRE, V18; SHEATH:6FR X 45CM; GUIDE CATHETER, PARENT 6FR,; GUIDE WIRE, V18; SHEATH:6FR X 45CM