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

Catalog Number	S-55-120-120-P6
Medical Device Problem Codes	Off-Label Use (1494); Difficult or Delayed Activation (2577); Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
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.(b)(4).Evaluation summary: visual inspection was performed on the returned device.The difficulties were unable to be confirmed as the stent had already been deployed.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.It was reported that the vessel diameter was 6mm.The supera instruction for use lists for a reference vessel diameter of 6mm, the stent diameter should be 6.0mm -6.5mm.Based on the reported information, it does not appear that using the undersized stent contributed to the difficulties.The investigation determined that the reported difficulties were related to case circumstances.It is likely that the delivery system was advanced forward during deployment causing the reported invagination of the stent and resulting in stent shortening.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mildly tortuous, heavily calcified, 95% stenosed mid to proximal right superficial femoral artery.The vessel was prepared with an unspecified 6x200mm balloon catheter at 14 atmospheres for two minutes, and a 6frx45cm non-abbott sheath was used.A 5.5x120 supera self-expanding stent system (sess) was advanced to the target lesion and deployed per the instructions for use; however, difficulty deploying the stent was noted.The stent partially deployed and due to invagination shortened after being fully deployed.The delivery system was removed under fluoroscopy.There were no adverse patient effects and 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: 8700740
• Report Number: 2024168-2019-04711
• Device Sequence Number: 13938427
• Product Code: NIP
• UDI-Device Identifier: 08717648226144
• UDI-Public: 08717648226144
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2019

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: 12/31/2020
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 9010262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/14/2019
• 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: 6F 45CM DESTINATION
• Patient Age: 85 YR