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	09/13/2016
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.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported difficulties.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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other 5.5x150 6fr 120cm supera peripheral stent system referenced is being filed under a separate manufacturing report number.
Event or Problem Description
It was reported that, with an unspecified 0.014 in guide wire advanced to the heavily calcified lesion in the heavily tortuous superficial femoral artery, an attempt was made to advance a 5.5x150 6fr 120cm supera peripheral stent system onto the guide wire, however, the supera was only able to be advanced approximately 1 inch onto the guide wire before becoming stuck (unable to advance or retract).As the supera had not yet entered patient anatomy, force was applied to retract the stuck supera from the guide wire.An attempt was made to advance another same size supera onto the same guide wire, but this supera was also only able to be advanced approximately 1 inch onto the guide wire before becoming stuck (unable to advance or retract).Force was applied to retract the stuck supera from the guide wire.Another (3rd) same size supera was able to be advanced over the same guide wire without issue and was successfully deployed, completing the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay.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: 5967865
• Report Number: 2024168-2016-06253
• Device Sequence Number: 617065
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: (01)08975370026337(17)180531(10)6060861
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/21/2016

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: 05/31/2018
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 6060861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2016
• Initial Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 52