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

Catalog Number	1012534-80
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
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.The device was not returned for analysis.Without having the device to examine, a cause for the reported difficulties could not be determined.It may be possible that the distal shaft was entrapped or restricted within the anatomy causing restriction between the shaft lumens, resulting in the inability to rotate the thumbwheel and deployment issue.However, this could not be confirmed.The additional treatment of opening the handle to deploy the stent was related 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 similar incidents.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 lesion in the right iliac artery.A 6.0x80mm x 135cm absolute pro vascular self-expanding stent system (sess) was advanced to the lesion and deployment was initiated.The dial on the sess handle would not continue to move at the point the stent was halfway deployed.The delivery system then locked up, and the physician then manually split open the sess handle to push the rod forward to deploy the remaining portion of the stent in the target lesion.The procedure concluded after the stent was deployed.It was confirmed that the delivery system was not kinked, and the thumbwheel was not difficult to turn during the stent deployment.There was no adverse patient effect 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: 8182733
• Report Number: 2024168-2018-09915
• Device Sequence Number: 2105390
• Product Code: NIO
• UDI-Device Identifier: 08717648176005
• UDI-Public: 08717648176005
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 07/31/2021
• Device Catalogue Number: 1012534-80
• Device Lot Number: 8080861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/19/2018
• 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: 63 YR
• Patient Weight: 43