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

Catalog Number	1012537-40
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
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.Visual inspection was performed on the returned device.It was confirmed that the strain relief was pulled out from the handle.It is likely the handle of the self expanding stent system was inadvertently mishandled during removal from the packaging.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 determined that the reported issue was likely due to inadvertent mishandling.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 an absolute pro self-expanding stent system (sess) was advanced to the right external iliac artery without resistance.During advancement, the proximal catheter, attached to the device handle, separated.The sess, containing the undeployed stent was removed from the anatomy without issue.A non-abbott device was used in replacement.There were no reported adverse patient effects and no clinically significant delay.There was no additional information provided regarding this issue.

• 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: 7313613
• Report Number: 2024168-2018-01558
• Device Sequence Number: 13482723
• Product Code: NIO
• UDI-Device Identifier: 08717648176227
• UDI-Public: 08717648176227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

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: 04/30/2020
• Device Catalogue Number: 1012537-40
• Device Lot Number: 7052361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR