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

Catalog Number 1012631-59

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat the iliac artery with moderate calcification, moderate tortuosity and 99% stenosis.Access was via the radial artery.Pre-dilatation was performed; however, it was not enough.There was difficulty with the anatomy during advancement of the 8x59 mm omnilink elite stent delivery system (sds) and during removal there was resistance with the anatomy and the stent came off of the balloon.The stent was ultimately deployed where it dislodged in the brachial artery.The target lesion was treated with additional balloon dilatation and another omnilink elite stent.There was a delay in the procedure but no reported harm to the patient.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 incidents.The reported difficulties and subsequent unexpected medical intervention and foreign body in patient appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect - impact code 4641 removed; 4614 added.

Event Description

It was reported that the procedure was to treat the iliac artery with moderate calcification, moderate tortuosity and 99% stenosis.Access was via the radial artery.Pre-dilatation was performed; however it was not enough.There was difficulty with the anatomy during advancement of the 8x59 mm omnilink elite stent delivery system (sds) and during removal there was resistance with the anatomy and the stent came off of the balloon.The stent was ultimately deployed where it dislodged in the brachial artery.The target lesion was treated with additional balloon dilatation and another omnilink elite stent.There was a delay in the procedure but no reported harm to the patient.Subsequent to the initially filed report, it was reported that the sds balloon was used to deploy the stent in the arm with a low inflation.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• 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: 18465359
• MDR Text Key: 332322195
• Report Number: 2024168-2024-00302
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: 08717648178528
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012631-59
• Device Lot Number: 3020141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG