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

Catalog Number	1012631-59
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2024168-2024-00302
• Device Sequence Number: 17928464
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: 08717648178528
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 07/31/2026
• Device Catalogue Number: 1012631-59
• Device Lot Number: 3020141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG