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

Catalog Number	1012631-29
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2019
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: a visual and functional were performed on the returned device.The reported stent damage and difficulty to remove were able to be confirmed.The reported failure to advance through the previously implanted stent was unable to be replicated in a testing environment as it was based on operational circumstances.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 identified no other similar incidents reported from this lot.The investigation determined the reported difficulties of failure to advance, difficult to remove and stent damage appear to be related to circumstances of the procedure.Based on the reported information, during advancement the sds encountered resistance with previously implanted stent causing the reported failure to advance and the bent/stretched stent damage, therefore resulting in the difficulty to remove the sds through the introducer sheath during retraction.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the iliac artery with no tortuosity and no calcification.A 6f non-abbott sheath was placed.Following the successful deployment of an unspecified stent, a 8.0 x 29 mm omnilink elite stent delivery system (sds) was advanced; however, met resistance with the deployed stent and the stent struts flared.The stent remained on the sds.The sds was attempted to be removed but resistance with the sheath was met.The sds and the sheath were therefore removed together as a single unit.There was no reported damage to the implanted stent.The procedure was successfully completed with a new sheath and a new unspecified sds.There were no adverse patient effects and no clinically significant delay in the procedure.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: 8664374
• Report Number: 2024168-2019-04335
• Device Sequence Number: 2087047
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: 08717648178504
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

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: 03/31/2022
• Device Catalogue Number: 1012631-29
• Device Lot Number: 8103141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 59