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

Catalog Number	S-55-120-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.The investigation determined the reported difficulties appear to be related to the circumstances of the procedure.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 identified no other incidents from this lot.Based on the information reviewed, 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 the entire length of the lower superficial femoral artery that was heavily calcified and totally occluded.A supera peripheral stent was successfully deployed.A second supera peripheral stent system 5.5 x 120 6f 120 cm was half way through the lesion when it was noticed to be getting close to the introducer sheath.The proximal marker was outside the sheath by approximately 20mm.The physician backed up the sheath, then continued to be advance; however the stent could not be deployed because the sheath was not backed up enough and tip and ratchet became trapped in the introducer sheath due to a significant kink which was observed after half of the stent had been deployed.The stent was visualized under fluoroscopy with an estimated 2-3cm un-deployed still in the sheath.The stent delivery system, including the stent and sheath, was removed together leaving only the interventional wire in place.A second angiography to the vessel was performed and using a new 6f sheath, another supera stent was deployed to complete the procedure.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.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: 6047900
• Report Number: 2024168-2016-07177
• Device Sequence Number: 18917077
• Product Code: NIP
• UDI-Device Identifier: 08975370026320
• UDI-Public: (01)08975370026320(17)171031(10)5113061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2016

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: 10/31/2017
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 5113061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 10/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6FSTENT: SUPERA
• Patient Age: 72 YR
• Patient Weight: 75