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	Difficult to Remove (1528); Material Separation (1562); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2019
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.Concomitant medical products: guide wire: cmde 18 300cm; sheath: 45cm 6fr destination (terumo).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 revealed no other incidents reported from this lot.The investigation was unable to determine a cause for the reported deployment issue.It may be possible that the distal sheath was bent or entrapped within in the anatomy such that the ratchet was unable to engage the stent properly, causing resistance with the thumbslide and preventing full deployment; however, this could not be confirmed.The difficulty removing, and tip detachment were due to case circumstances and the result of the deployment difficulty.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 a de novo, 99% stenosed, heavily calcified lesion in the narrow, mildly tortuous proximal femoral artery.The lesion was pre-dilated with multiple balloon catheters and a 6.0mm supera was deployed in the distal lesion.Another 6.0x80mm supera self expanding stent system (sess) was attempted to deploy at the proximal end of the target lesion however the stent was not able to be completely deployed with the thumb slide.The physician tried to slide the deployment lock, but there was no difference.A non-abbott 6fr sheath was advanced to retrieve the sess.Resistance was met retracting the sess and the tip of the device caught on the sheath, causing it to separate.The supera stent was able to be completely deployed during retraction and the tip was retrieved with a snare device.The stent was ultimately implanted in the intended area.There was no adverse patient sequela and there was no 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: 8558568
• Report Number: 2024168-2019-03356
• Device Sequence Number: 11339892
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 06/30/2020
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 8071861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2019
• Initial Report FDA Received Date: 04/26/2019
• 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