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

Catalog Number	1012630-19
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous and moderately calcified subclavian artery.A 7.0 x 19 mm omnilink elite vascular stent system was used and crossed the lesion; however, the device met resistance with the anatomy during advancement.Therefore, the stent system was retracted and met resistance with the anatomy during removal as well.The stent then became entangled with the anatomy; causing the stent to dislodge from the balloon and prematurely expand.An unspecified coronary balloon dilatation catheter was therefore used to post-dilate the stent as it was not properly apposed to the lesion.No further treatment was performed.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The reported difficulties appear to be due to challenging 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 lot revealed no other incidents.It should be noted that the omnilink elite instructions for use (ifu) 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.It could not be determined that using the omnilink elite to treat the subclavian contributed to the difficulty.Additionally, the ifu states: should unusual resistance be felt at any time during either lesion access or removal of the delivery system post-stent implantation, the entire system should be removed as a single unit.In this case, it was reported that when resistance was encountered during advancement, an attempt was made to remove the device.However, during the attempt to remove, resistance was again encountered and the stent dislodged from the balloon.Based on this reported information, there is no indication to suggest that user error contributed to the difficulties as the anatomical conditions appear to be the contributing factor.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
Subsequent to the initial report, additional information was received.The stent struts of the device became flared and stretched when it became entangled with the anatomy.The stent was then apposed to the target lesion.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: 7484544
• Report Number: 2024168-2018-03273
• Device Sequence Number: 1543167
• Product Code: NIO
• UDI-Device Identifier: 08717648178450
• UDI-Public: 08717648178450
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 1012630-19
• Device Lot Number: 7062241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 115