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

Catalog Number	1012631-19
Medical Device Problem Codes	Off-Label Use (1494); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
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.(b)(4).Visual inspection was performed on the returned device.The dislodged stent was confirmed.The failure to advance 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 of the reported revealed no other incidents.It should be noted that the omnilink elite instruction for use states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of 5.0 mm and 11.0 mm, and lesion lengths up to 50 mm.In this case, it could not be determined if using the omnilink elite off-label cause or contributed to the reported difficulties.The investigation determined that the reported difficulties were due to case circumstances.It is likely that after failing to advance, the stent had become loose on the balloon due to interaction with the anatomy and dislodged when the stent interacted with the valve during removal.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 a stenosed lesion in the left subclavian with heavy calcification.A 8.0 x 19 mm omnilink elite stent delivery system (sds) was advanced; however, failed to cross the lesion due to the patient anatomy.On removal of the sds with no reported resistance, the stent dislodged at the site of the unspecified touhy bleed back control valve.The stent was therefore simply manually removed and a new unspecified omnilink elite sds was advanced successfully to complete the procedure.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: 8597429
• Report Number: 2024168-2019-03725
• Device Sequence Number: 1639402
• Product Code: NIO
• UDI-Device Identifier: 08717648178498
• UDI-Public: 08717648178498
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/09/2019

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: 04/30/2022
• Device Catalogue Number: 1012631-19
• Device Lot Number: 8111541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 62