MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number 1012624-39

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device was not returned for evaluation.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 and/or complaints from this lot.Based on the information provided, the reported difficulties were due to procedural circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that this was a peripheral percutaneous intervention treating the bilateral iliac arteries, moderately calcified lesions.Two omnilink elite stents were successfully placed.Imaging was performed with an unspecified catheter, when the catheter snagged the left iliac, 8x39mm omnilink elite stent.The stent was dragged down to the bifurcation at the common femoral with imaging catheter removal.The same imaging catheter was used to push the stent back to the desired implantation site.The stent was successfully re-expanded and was implanted at the desired location.There was no stent damage observed, however, as a precaution, another stent was successfully implanted, overlapping the 8x39mm omnilink elite stent.Reportedly, the procedure ended with good results noted.There was no adverse patient sequela and there was no clinically significant delay.No additional information was provided regarding this issue.

• Brand Name: OMNILINK ELITE
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9397610
• MDR Text Key: 168684523
• Report Number: 2024168-2019-14024
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: 08717648179303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 1012624-39
• Device Lot Number: 7091941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANTED OMNILINK ELITE STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 91