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

Catalog Number 11012-59

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Activation Failure (3270)

Patient Problem Vascular Dissection (3160)

Event Date 10/04/2023

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 performed to treat a lesion in the iliac artery.A 6fr sheath was placed and a 9x39mm omnilink elite balloon expandable stent (bes) was being advanced when met resistance with the introducer sheath.The bes was attempted to be deploy; however, after multiple attempts to pushed out the stent did not come out of the sheath and completely failed to deploy.During removal, the bes met resistance with the introducer sheath and a dissection at the puncture site was noted; therefore, a cut down was performed and the device was removed as a single unit.There was a delay in the procedure; however, there were no adverse patient sequela.

Event Description

It was reported that the procedure was performed to treat a lesion in the iliac artery.A 6fr sheath was placed and a 9x39mm omnilink elite balloon expandable stent (bes) was being advanced when met resistance with the introducer sheath.The bes was attempted to be deploy; however, after multiple attempts to pushed out the stent did not come out of the sheath and completely failed to deploy.During removal, the bes met resistance with the introducer sheath and a dissection at the puncture site was noted; therefore, a cut down was performed and the device was removed as a single unit.There was a delay in the procedure; however, there were no adverse patient sequela.Subsequent to the initially filed report it was reported that the omnilink elite sds did not fully exit the introducer sheath and deployment was not attempted.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 patient effects of dissection and surgical intervention are listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficult to advance and difficult to remove; however, the subsequent surgical intervention appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of vascular dissection, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3: device returning updated from yes to no.H6: medical device problem code 3270 removed.

• 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: 18024616
• MDR Text Key: 326789701
• Report Number: 2024168-2023-11942
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 11012-59
• Device Lot Number: 1091841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2021
• 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: 6FR SHEATH
• Patient Outcome(s): Required Intervention