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

Catalog Number	1012624-59
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
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 inspection was performed on the returned device.The dislodged stent was confirmed.The failure to advance, stent damage and resistance was unable to be replicated as it was based on case circumstances.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 revealed no other incidents.The failure to advance, resistance and stent dislodgment were likely due to anatomical conditions.The investigation determined that the reported difficulties were due to case circumstances and 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 lesion located in the left iliac.The 8.0 mm/59 mm otw omnilink stent delivery system (sds) was advanced; however, would not advance over the aortic arch.During retraction of the sds the stent caught on the lip of the introducer sheath and dislodged from the balloon inside the sheath.The sheath, with the first 3/4 of the stent implant inside, was removed from the anatomy; however, the remaining 1/4 of the stent (still intact) had to be removed with the fingers as it was elongating.The decision was made not to continue treatment and the procedure ended.There were no adverse patient sequela reported.No additional information was provided.

• 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: 6919477
• Report Number: 2024168-2017-07999
• Device Sequence Number: 16411787
• Product Code: NIO
• UDI-Device Identifier: 08717648179310
• UDI-Public: 08717648179310
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• 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): 10/05/2017

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: 06/30/2020
• Device Catalogue Number: 1012624-59
• Device Lot Number: 7010541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 54