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

Catalog Number	1012528-40
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
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.(b)(4).The device was not returned for analysis.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other incidents reported from this lot.The indication for use listed in the instruction for use states: the absolute pro.035 peripheral self-expanding stent system is intended for the stenting of peripheral arteries as an adjunct to percutaneous transluminal angioplasty (pta) and for the palliation of malignant strictures in the biliary tree.In this case, it could not be determined if using the absolute pro in an incorrect anatomy contributed to the difficulties.The investigation was unable to determine a cause for the reported inaccurate delivery.It may be possible that the distal sheath was restricted or entrapped within the anatomy such that when the sheath finally released and the stent deployed, the stent jumped due to the built-up tension within the shaft lumens of the delivery system causing a spring like release of the stent.However, this could not be confirmed.The resistance during advancement was due to anatomical conditions.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 an arteriovenous fistula in the basilic vein with heavy tortuosity.A 6.0mmx40mmx80cm absolute pro self expanding stent system was advanced with resistance from the anatomy.On deployment the stent jumped.There was no reported problems with the deployment mechanism.The stent was deployed within the target lesion.No additional intervention was required.There were 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: 7789685
• Report Number: 2024168-2018-06299
• Device Sequence Number: 13750145
• Product Code: NIO
• UDI-Device Identifier: 08717648175541
• UDI-Public: 08717648175541
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/16/2018

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: 08/31/2020
• Device Catalogue Number: 1012528-40
• Device Lot Number: 7091861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 72