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

Catalog Number	1012535-40
Medical Device Problem Codes	Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
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.Evaluation summary: visual inspection and functional inspection was performed on the returned device.The failure to deploy and resistance with the thumbwheel was not confirmed due to the stent already being deployed and out of the delivery system.The resistance with the anatomy was not confirmed as it was due to case circumstances.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 other incidents.The investigation was unable to determine a cause for the initial deployment failure and thumbwheel resistance.It may be possible that the distal shaft was bent or entrapped in the anatomy preventing the shaft lumens moving freely and preventing the thumbwheel from rotating; however, this could not be confirmed.The resistance with the anatomy was due to case circumstances.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 performed to treat a distal lesion below the bifurcation of the popliteal artery with calcification and no tortuosity.A 6f sheath was placed and the lesion was pre-dilated with an unspecified balloon dilatation catheter.A 7.0mm x40 mm x 135cm absolute pro vascular self expanding stent system (sess) was advanced with slight resistance from the anatomy.On deployment of the stent of the sess, the thumbslide [thumbwheel] became stuck and would not move.The stent of the sess did not appear exposed on imaging and the sess was therefore removed from the patient anatomy.No resistance on removal was felt.Outside of the anatomy, the distal end of the stent was noted to be exposed and the thumbslide [thumbwheel] remained stuck.The procedure was successfully completed with a non-abbott stent.There was no adverse patient effects and no 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: 7855598
• Report Number: 2024168-2018-06945
• Device Sequence Number: 1565473
• Product Code: NIO
• UDI-Device Identifier: 08717648176067
• UDI-Public: 08717648176067
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/07/2018

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: 07/31/2020
• Device Catalogue Number: 1012535-40
• Device Lot Number: 7081461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/07/2018
• 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: SHEATH: 6F
• Patient Age: 67 YR
• Patient Weight: 111