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

Model Number	S-50-040-120-P6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional supera referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a distal superficial femoral artery.Pre-dilatation was performed by an unspecified balloon.A 5x40mm supera stent was advanced to the lesion and deployment initiated.However, the introducer sheath was far away from the proximal end of the stent during deployment which caused the stent to only partially deploy (proximal end of stent remained on catheter).The device was simply withdrawn.It was attempted to advance another same size supera, but the same issue occurred and therefore removed.Both delivery systems were not removed under fluoroscopy.There were no reported issues with the thumbslide mechanism.A non-abbott device was used to successfully complete the procedure.There was no adverse patient effects 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 deployment issue was not confirmed as the stent had already been fully deployed.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 revealed no indication of a lot specific product issue.It should be noted that the supera instruction for use states: "confirm under fluoroscopy that the entire supera stent has emerged from the outer sheath and is released." in this case, removal without fluoroscopy does not appear to have contributed to the deployment difficulty.The investigation was unable to determine a cause for the reported deployment issue.It may be possible that the reported deployment issue was the result of anatomical conditions.It is possible that the distal sheath of the delivery system was entrapped or bent within the anatomy such that the ratchet was unable to properly engage the proximal segment of stent preventing full deployment and release of the stent form the delivery system; however, this could not be confirmed.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 distal superficial femoral artery.Pre-dilatation was performed by an unspecified balloon.A 5x40mm supera stent was advanced to the lesion and deployment initiated.However, the introducer sheath was far away from the proximal end of the stent during deployment which caused the stent to only partially deploy (proximal end of stent remained on catheter).The device was simply withdrawn.It was attempted to advance another same size supera, but the same issue occurred and therefore removed.Both delivery systems were not removed under fluoroscopy.There were no reported issues with the thumbslide mechanism.A non-abbott device was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.Correction: the introducer sheath was far away from the proximal end of the stent during deployment.Once the device reached the lesion, deployment was activated and the stent only partially deployed (proximal end of stent remained on catheter).] 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: 10978813
• Report Number: 2024168-2020-10343
• Device Sequence Number: 11836080
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: 08717648211737
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/28/2021

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: 02/28/2022
• Device Model Number: S-50-040-120-P6
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 0032061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1