MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number	1012631-29
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
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.Evaluation summary: visual and dimensional inspection was performed on the returned device.Difficulty positioning through an introducer sheath and stent damage was observed.Additionally, the proximal end of the stent implant moved 7mm distal from its original crimp position.The failure to advance was unable to be replicated as it was based on case circumstances.The failure to advance, resistance and stent damage was likely due to anatomical conditions.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported revealed no other incidents.The investigation determined that the reported difficulties were due to case circumstances.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 de novo lesion located in the common iliac artery (cia) with heavy tortuosity and heavy calcification that was 90% stenosed.Resistance was felt with the anatomy and other device [guide catheter] during the advancement of a 8.0 x 19 mm omnilink elite stent delivery system (sds) to the lesion and it would not cross it.During the attempt to cross, the sds was pushed and pulled resulting in flared struts on the stent implant.The device was removed from the anatomy.A new omnilink elite was used to complete the procedure.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.The return device analysis indicated that the stent moved distally from the balloon.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6540994
• Report Number: 2024168-2017-03858
• Device Sequence Number: 980791
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: (01)08717648178504(17)181130(10)5060441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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: 11/30/2018
• Device Catalogue Number: 1012631-29
• Device Lot Number: 5060441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: PARENT