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

Catalog Number	S-60-080-120-P6
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Perforation (2001)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspection were performed on the returned device.The tip detachment was confirmed.The reported stent migration and subsequent patient effects were not confirmed as it was based on case circumstances.The investigation determined that the reported difficulties and subsequent patient effects were likely use related.Returned device analysis noted that both locks were returned in the unlocked position.Failing to retract the tip and lock the system lock likely caused the tip to catch on the stent during withdrawal causing the stent to move and resulting in the reported tip detachment and perforation.It should be noted that the supera instruction for use (ifu) instructs: 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.In this case, failing to retract the thumbslide and lock the system lock likely caused the reported difficulties.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 incidents.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 performed to treat a calcified lesion in the right superficial femoral artery (sfa) with a vessel diameter of 6.5mm.A 6f non-abbott introducer sheath was placed at the left common femoral artery (cfa) and an unspecified.018 guide wire was advanced to the lesion.Pre-dilatation was performed and a 6.0x80mm supera self-expanding stent system (sess) was advanced to the lesion without resistance.The stent was deployed without any noted difficulty with the thumbslide.The thumbslide was fully retracted to the start position; however, the physician could not recall if both the system and deployment levers were locked prior to removal.The sess was removed under fluoroscopy without reported resistance; however, the stent was noted to have moved a couple of centimeters from the deployed location.During sess removal from the patient anatomy, the tip detached from the sess inside the sfa and the sess caused a perforation at the left cfa.A covered stent was implanted to treat the perforation in the left cfa.Additionally, an attempt to retrieve the detached tip was made by placing an 8f sheath at the right cfa.A snare device was advanced and the tip was removed from the right sfa; however, the detached tip could not be pulled through the introducer sheath.The detached tip remains embedded in the subcutaneous tissue.There was no adverse patient sequela.There was a delay in the procedure due to the additional treatment for the perforation and attempted tip retrieval.No additional information was 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: 7737598
• Report Number: 2024168-2018-05920
• Device Sequence Number: 16789354
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 7020761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR