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

Catalog Number UNK OMNILINK ELITE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Renal Failure (2041); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); Respiratory Failure (2484); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 04/30/2023

Event Type  Injury  

Event Description

It was reported through the pmcf (post market clinical follow-up) report, that the omnilink elite stent may be related to the adverse patient effects of myocardial infarction, pulmonary complications, renal complications, access site complications, amputation / surgical intervention, occlusion, thrombosis, embolization, dissection, perforation, re-stenosis, revascularization and re-hospitalization.Details are listed in the attached article, titled post market clinical follow-up evaluation report balloon expandable peripheral stent systems.Please see the attached post market clinical follow up evaluation report for specific information.

Manufacturer Narrative

A2: age - average.B3: date of event: estimated.D4: the udi is unknown because the part number and lot number were not provided.D6a: date of implant: estimated.Literature attachment: article title: e-179616 pmcf rpt2131863, rev d - post market clinical follow-up evaluation report balloon expandable peripheral stent systems.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional patient effect of death and malfunctions reported in the article are captured under separate medwatch report.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of occlusion, embolism, myocardial infarction, renal failure, perforation, stenosis, dissection, thrombosis, and surgical intervention are listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use as known patient effects of stenting procedures.A conclusive cause for the reported patient effects of occlusion, embolism, myocardial infarction, renal failure, perforation, stenosis, dissection, thrombosis, respiratory failure, unspecified tissue injury and surgical intervention, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment of unexpected medical intervention (additional therapy/non-surgical treatment) appears 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.

• 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: 17801473
• MDR Text Key: 324113100
• Report Number: 2024168-2023-10462
• Device Sequence Number: 1
• Product Code: NIO
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK OMNILINK ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization; Disability; Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White