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

Catalog Number 11010-39

Device Problems Inflation Problem (1310); Leak/Splash (1354); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly calcified, 85% stenosed lesion in the external iliac artery.A 7x39mm omnilink elite 35 vascular balloon-expandable stent system (bess) was advanced to the target lesion.An attempt was made to inflate the bess to deploy the stent however, the balloon only partially inflated, and the stent only partially expanded.Contrast was noted leaking into the artery through the tip of the balloon.This was repeated several times using different inflation devices and every time with the same results.It was decided to remove the bess, however the balloon was partially inflated, and the stent came off of the balloon.A new balloon was introduced through the badly damaged and deformed stent to be able to crush it against the wall and subsequently a new, 7x59mm omnilink stent was deployed successfully.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 similar incidents from this lot.A conclusive cause for the reported difficulties cannot be determined; however, the subsequent device embedded in tissue or plaque and unexpected medical intervention 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.

• 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: 14438620
• MDR Text Key: 292058173
• Report Number: 2024168-2022-05374
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11010-39
• Device Lot Number: 1112941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: 0.035X260CM TERUMO GUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80 KG