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

Catalog Number UNK OMNILINK ELITE

Device Problem Device Damaged by Another Device (2915)

Patient Problem Stenosis (2263)

Event Date 12/21/2020

Event Type  Injury  

Event Description

It was reported through a research article, identifying the omnilink elite balloon-expandable stent (bes) system as follows: this article demonstrates how atherectomy devices can damage the stent struts and lead to pseudoaneurysms.In this case, there was a risk of restenosis or thrombosis in the damaged strut area, so a covered stent was placed, proving that a stent graft is a good treatment option of the pseudoaneurysm caused by the atherectomy procedure.The patient presented at an unknown hospital, with in-stent re-stenosis of an implanted 7×39mm omnilink elite balloon-expandable stent (bes).The patient received endovascular therapy (evt) and atherectomy was performed followed by use of an unspecified drug-coated balloon.Several months after the evt, and atherectomy with ballooning procedure, a pseudoaneurysm occurred and did not resolve on its own, so the patient visited a new hospital for treatment.Via imaging, a damaged stent strut was noted at the previous implanted 7×39mm omnilink elite balloon-expandable stent system (bess).A 31mm sized pseudoaneurysm was observed in the damaged strut area of the superficial femoral artery (sfa).Evt, and treatment with a covered stent was performed without issue.The final angiography, showed the pseudoaneurysm was completely treated.Details are listed in the attached article, titled: successful management of iatrogenic arterial pseudoaneurysm caused by rotational atherectomy.Please see article for additional information.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3, b6, d6a: dates estimated the udi number is not known as the part and lot number were not provided.

Manufacturer Narrative

The devices were 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 investigation was unable to determine a conclusive cause for the reported device damaged by another device; however, the subsequent unexpected medical intervention (additional therapy/non-surgical treatment) appears to be related to the operational context of the procedure.A conclusive cause for the reported patient effect(s) of stenosis, and the relationship to the product, if any, cannot be determined.The reported patient effect of stenosis is listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use as a known patient effect of coronary stenting procedures.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: 16931088
• MDR Text Key: 315209085
• Report Number: 2024168-2023-05157
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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: UNK OMNILINK ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/14/2023
• 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
• Treatment: ADMIRAL 5 × 40 MM BALLOON MEDTRONIC VASCULAR; COVERED STENT, LIFESTREAM; INTRAVASCULAR ULTRASOUND (IVUS, EAGLE EYE; JETSTREAM XC ATHERECTOMY CATHETER 2.4/3.4 MM; REGALIA (ASAHI INTECC CO LTD, AICHI, JAPAN) WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male