MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	S-55-080-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspections were performed on the returned device.The tip detachment was confirmed.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 did not reveal a lot specific product issue.The supera instruction for use (ifu) instructs that following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.The investigation determined that the cause for the reported the reported difficulties were due to use error.It is likely that the thumbslide was not retracted and the system lock was not locked prior to removal causing the tip to catch on the stent and detach.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 a supera stent was implanted in the superficial femoral artery to popliteal artery, mild-moderately calcified lesion without issue.It was initially thought that the thumbslide was fully retracted and locked, so the delivery system was ready for removal.The guidewire was removed from the patients anatomy.After removal, it was then noted that the supera delivery systems tip had separated.The tip was hanging out of the sheath and was located inside the guide catheter.All was removed from the patients anatomy as a single unit.The supera stent remained implanted at the intended site without any issue.Once the supera delivery system was removed, it was then observed that the thumbslide had not been fully retracted and locked prior to supera delivery system removal.There were no adverse patient effects and there was no clinically significant procedural delay.There was no additional information provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6337901
• Report Number: 2024168-2017-01284
• Device Sequence Number: 829784
• Product Code: NIP
• UDI-Device Identifier: 08975370026306
• UDI-Public: (01)08975370026306(17)170731(10)5081061
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2017

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: 07/31/2017
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 5081061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR