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

Model Number	S-60-120-120-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	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 one other similar incident reported from this lot.Based on the review of similar incident there is no indication of a lot specific product quality issue.The investigation was unable to determine a conclusive cause for the reported mechanical issues that resulted in the failure to deploy.It may be possible that the distal sheath of the delivery system was entrapped or bent in the anatomy possibly due to the iliac artery calcification and tortuosity such that the ratchet was unable to properly engage the stent resulting in difficulty advancing the thumbslide and deployment difficulty; however, without having the devices to examine, this could not be confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Na.
Event or Problem Description
It was reported that on (b)(6) 2020, a percutaneous intervention was performed on the superficial femoral artery (sfa), with heavy calcification and 100% stenosed, concentric lesion.Access was obtained from the contralateral approach.Following pre-dilatation, a 6.0x120mm supera stent delivery system (sds) advanced to the lesion for implantation.During deployment, the stent partially deployed, approximately 2 centimeters, when the thumb slide was unable to slide/move anymore.The stent was unable to deploy any further.The stent was not deployed and device removed without issue.Per physician, the issue with the 6.0x120 supera device was possibly due to the iliac artery calcification and tortuosity.It was determined that stent deployment from the contralateral approach was too difficult so another access site, on the ipsilateral side was made.Another supera stent, a 6.0x80mm stent, was implanted without further issues reported.Residual stenosis was at 10%.There was no adverse patient effect and there was no clinically significant delay.No additional information was provided regarding this issue.

• 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: 11038203
• Report Number: 2024168-2020-10696
• Device Sequence Number: 16405874
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 05/31/2021
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 9061961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1