MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012534-40
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
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.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific product issue.The investigation determined the difficulties were 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 moderately calcified lesion in the superficial femoral artery.As the absolute pro self expanding stent system (sess) was being advanced onto an unspecified guide wire that was at the target lesion, resistance was noted and it felt like the sess was sticking to the guide wire.The physician could not remember if guide wire had been wiped down so the sess was attempted to be removed.There was resistance with the guide wire during removal of the sess.As the sess was being backed off of the guide wire, the sheath pulled back and the distal part of the stent deployed and became flowered.Reportedly, the stent was confirmed to not be exposed prior to loading the sess onto the guide wire.Another absolute pro sess and guide wire were used to successfully complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 8191390
• Report Number: 2024168-2018-10008
• Device Sequence Number: 2069800
• Product Code: NIO
• UDI-Device Identifier: 08717648175985
• UDI-Public: 08717648175985
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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: 04/30/2021
• Device Catalogue Number: 1012534-40
• Device Lot Number: 8051861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR