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

Catalog Number	S-55-150-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2017
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.Device - failure to follow steps/instructions.Evaluation summary: visual inspection was performed on the returned device.The reported difficulties were unable to be confirmed as the stent had already been fully deployed.Based on the reported information, the difficulties were user related.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 should be noted that the supera instruction for use instructs: while maintaining increased magnification from step 3, rotate the deployment lock to the unlocked position.The investigation determined the reported difficulties were due to user error.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 moderately calcified lesion in the mid superficial femoral artery.A 5.5x150mm supera peripheral stent system was advanced to the lesion and thought to have been deployed; however, when the device was removed the stent was still on the device.It was noted that the physician did not unlock the device when deploying it.Additionally, resistance was felt when removing the device and the stent stretched greater than 10%.The procedure was successfully completed with an unknown stent.There was no clinically significant delay in the procedure and no adverse patient effects.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: 6477478
• Report Number: 2024168-2017-02990
• Device Sequence Number: 1054398
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: (01)08975370026337(17)180831(10)6092261
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 08/31/2018
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 6092261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1