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

Catalog Number	1012535-80
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
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 reported difficult to deploy was unable to be confirmed as the device was returned disassembled and the thumbwheel gear was not returned.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 identified no other similar incidents from this lot.The investigation determined the reported difficulty appears to be related to circumstances of the procedure as it is likely that the noted kink on the shaft occurred during procedure which contributed to the reported difficulty deploying the stent.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.
Event or Problem Description
It was reported that the procedure was to treat a lesion with chronic total occlusion (cto) located in the superficial femoral artery (sfa) that is heavily calcified.Resistance was not felt during advancement of the 7.0/80 mm/135 cm absolute pro stent delivery system (sds) through lesion and it crossed successfully.The stent was expanded about 1/4 of the length when the thumbwheel of the device became stuck and would not continue to deploy the stent.The handle was disassembled in order to manually work the internal mechanism to deploy the stent successfully.There were no adverse patient effects or clinically significant delay in the procedure reported.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: 6215769
• Report Number: 2024168-2016-09392
• Device Sequence Number: 1419211
• Product Code: NIO
• UDI-Device Identifier: 08717648176081
• UDI-Public: (01)08717648176081(17)160826(10)6082661
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 1012535-80
• Device Lot Number: 6082661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2016
• Initial Report FDA Received Date: 12/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR