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

Model Number	S-65-120-120-P6
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.The 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 performed to treat a lesion in a densely calcified left popliteal / distal superficial femoral artery lesion.The patient had previously implanted stents in the vessel and a new area of stenosis was noted distal to the implanted stents.The supera stent delivery system was advanced through an unspecified 6 french sheath and advanced to the target site without issue.Deployment was initiated.After the stent was partially deployed, deployment stopped.The thumbslide was able to advance without resistance, but it seemed as if the ratchet was not engaging and the stent would not deploy.The physician tried rotating the delivery system, in an attempt to engage the ratchets, but the stent would not deploy.The decision was made to remove the stent, stent delivery system and guide wire as a single unit.No attempt was made to remove the stent delivery system from the guide wire; the physician chose to remove all devices as a single unit to prevent patient injury.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported difficulties were unable to be confirmed as the stent was already fully deployed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.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: 9950509
• Report Number: 2024168-2020-03576
• Device Sequence Number: 11593157
• Product Code: NIP
• UDI-Device Identifier: 08717648226304
• UDI-Public: 08717648226304
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: 08/31/2021
• Device Model Number: S-65-120-120-P6
• Device Catalogue Number: S-65-120-120-P6
• Device Lot Number: 9091161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR