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

Catalog Number UNK OMNILINK ELITE

Device Problem Off-Label Use (1494)

Patient Problems Dyspnea (1816); Stenosis (2263)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 1494- indication for use.The additional omnilink elite stent device(s) referenced in b5 is/are filed under separate medwatch report number(s).D4: the udi number is not known as the part and lot number were not provided.B3, b6, d6a: dates estimated.Literature attachment: article intravascular ultrasound guided drug coated balloon venoplasty for in-stent restenosis in pulmonary veins stenosis.A case report attachedna.

Event Description

It was reported via a case study that a patient underwent pulmonary vein radiofrequency ablation in march 2017.Four months after the index procedure, the patient was admitted for dyspnoea and pulmonary vein stenosis was diagnosed.In august of 2017 the patient underwent percutaneous treatment.A 10x19mm omnilink elite stent was implanted in the left superior pulmonary vein (lspv), an 8x19mm omnilink elite stent was implanted in the left inferior pulmonary vein (lipv) and a 7x16mm omnilink elite was implanted in right inferior pulmonary vein (ripv).Twenty months later, the patient began to experience dyspnoea and ct confirmed severe in-stent restenosis (isr) of all treated veins and new stenosis in right superior pulmonary vein (rspv).Intravascular ultrasound followed by drug coated balloon angioplasty were performed successfully.Following treatment there was no residual pressure gradient.Medication was given for 3 months.At the 1 year follow-up, there was no new symptoms and the patient remained in sinus rhythm.Details are listed in the attached article, titled "intravascular ultrasound-guided drug-coated balloon venoplasty for in-stent restenosis in pulmonary veins stenosis: a case report".No additional information was provided.

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.It was reported that the omnilink was used for a pulmonary vein radiofrequency ablation.It should be noted that the omnilink elite instructions for use (ifu) states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of = 5.0 mm and = 11.0 mm, and lesion lengths up to 50 mm.It is possible the ifu deviation contributed to the reported event.The reported patient effect of stenosis is listed in the omnilink elite® vascular balloon-expandable stent system, electronic ifu as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects of dyspnea and stenosis, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment(s) of unexpected medical intervention (additional therapy/non-surgical treatment) and medication required (treatment with medication) 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: 16939417
• MDR Text Key: 315302549
• Report Number: 2024168-2023-05209
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 06/19/2023

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: 05/16/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 06/19/2023
• 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: 10X19MM OMNILINK ELITE STENT
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female