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

Catalog Number	1012532-40
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 electronic complaint handling database revealed no other incidents reported from this lot.The investigation was unable to determine a cause for the reported inaccurate delivery.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other absolute pro device is filed under separate medwatch report.
Event or Problem Description
It was reported that during a procedure of the heavily tortuous, de novo left and right common iliac artery (cia) the 10x40x135mm absolute stent was advanced from the left brachial to the lesion in left cia and a 10x40x80mm absolute pro stent was advanced from the right sfa (ipsilateral retrograde approach) to the lesion in right cia.It was noted that during deployment at the same time both stents jumped not fully in the target lesion.One each 8 x 40 mm additional stent was used to fully cover both target lesion locations without issue.There was no reported adverse patient effect.There was no reported 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: 6661656
• Report Number: 2024168-2017-05275
• Device Sequence Number: 57884
• Product Code: NIO
• UDI-Device Identifier: 08717648175848
• UDI-Public: (01)08717648175848(17)190731(10)6081561
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

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: 07/31/2019
• Device Catalogue Number: 1012532-40
• Device Lot Number: 6081561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1