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

Catalog Number	S-65-120-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the calcified distal superficial femoral artery/popliteal artery.Pre-dilatation was performed and the supera stent delivery system was advanced to the target lesion.Deployment was initiated and the thumbslide was advanced.The stent began moving forward; however, the physician commented that the stent delivery system also seemed to move forward.Resistance was felt when advancing the thumbslide.The stent was deployed; however, the stent elongated approximately 3-4 cm.Due to the length of the lesion, two stents were planned.A second supera stent, a 6.5 x 80 mm supera, was deployed so that it overlapped the elongated stent portion and covered the remaining lesion.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspection and scanning electron microscopy (sem) analysis were performed on the returned device.The reported deployment issue, resistance and stretched stent were unable to be confirmed as the stent was fully deployed and remains in the patient.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.

• 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: 7912581
• Report Number: 2024168-2018-07426
• Device Sequence Number: 2063852
• Product Code: NIP
• UDI-Device Identifier: 08717648226304
• UDI-Public: 08717648226304
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 10/02/2018

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: 11/30/2019
• Device Catalogue Number: S-65-120-120-P6
• Device Lot Number: 7120161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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: 6F SHEATH
• Outcome Attributed to Adverse Event: Required Intervention