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

Model Number	S-65-150-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2017
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.Evaluation summary: visual inspections were performed on the returned device.The deployment difficulty was unable to be confirmed as the stent had already been deployed.The tip detachment 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 indication of a lot specific product issue.The investigation was unable to determine a conclusive cause for the reported deployment issue.The tip detachment was likely due to operational context.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 lesion located in the mid-superficial femoral artery that was heavily calcified.Near the end of deployment of the supera peripheral stent 6.5 x 150 6f 120 cm, the ratchet mechanism would not release the stent out from the sheath.The physician moved the thumbslide back and forth and locked and unlocked the system and the stent finally deployed.The thumbslide was fully retracted to the start position and both the system and deployment levers locked prior to removal of the stent delivery system (sds) however when the sds was being retracted, the nose cone separated.Fortunately, the separated nose cone stuck to the wire and was able to be pulled around sheath.The physician then used a hemostat to pull it out of the sheath.No adverse patient effect or delay.No additional information was reported.

• 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: 6679262
• Report Number: 2024168-2017-05528
• Device Sequence Number: 10774759
• Product Code: NIP
• UDI-Device Identifier: 08975370026399
• UDI-Public: (01)08975370026399(17)180430(10)6050661
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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: 04/30/2018
• Device Model Number: S-65-150-120-P6
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 6050661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1