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

Catalog Number	S-50-040-120-P6
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577); Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and functional inspection was performed on the returned device.The reported deployment issue and resistance were unable to be confirmed as the stent had already been fully deployed.The tip separation 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 revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.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 during a procedure of the moderately calcified, proximal right superficial femoral, after vessel pre-dilatation, the supera stent was half-way deployed when the thumbslide rachet slipped and the stent could not be deployed.Multiple steps were taken to re-engage the mechanism when the tip detached.The stent eventually was fully deployed with the tip in the vessel; however, with a suboptimal apposition.A snare device was used to retrieve the detached tip from the vessel.Additionally, during the tip retrieval attempts, a non-abbott guide wire tip became dislodged and detached.This was a tandem procedure and the patient was scheduled for a vascular surgical intervention unrelated to the stent procedure.During the surgery, the guide wire tip was removed along with the supera stent.There was no reported adverse patient sequela or a clinically significant delay in 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: 7771008
• Report Number: 2024168-2018-06160
• Device Sequence Number: 19287455
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: 08717648211737
• 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
• Device Implanted Year: 2018
• Device Explanted 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): 08/09/2018

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: 03/31/2020
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 8041761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/09/2018
• 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: 78 YR
• Patient Weight: 75