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

Catalog Number UNK OMNILINK ELITE

Device Problems Stretched (1601); Patient-Device Incompatibility (2682); Material Deformation (2976); Migration (4003)

Patient Problems Ischemia (1942); Pain (1994); Obstruction/Occlusion (2422); Diminished Pulse Pressure (2606); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 04/01/2018

Event Type  Injury  

Event Description

It was reported through a research article that the procedure was performed to treat an occlusion in the right common iliac artery performed two year earlier with a 9.0x59mm omnilink elite baloon expandable stent.Four months after the first procedure, the patient presented limb ischemia and the angiography confirmed the total occlusion.Therefore, a 8.0x120 mm non-abbott was implanted through the external iliac artery to the common femoral artery and a 9.0x59mm omnilink elite balloon expandable stent was implanted between them.The patient was medicated with dual antiplatelet therapy for at least one year; however, approximately two years later, the patient was readmitted with recurrent pain in the right leg and the angiography confirmed the total occlusion of the previous implanted stents.An additional reintervention with a balloon angioplasty was performed through the axillary access and nine months after the following procedure, the patient was readmitted to the hospital with critical limb ischemia in the right leg for two days.A duplex ultrasound confirmed the total occlusion.Therefore, an urgent catheter-based angiography was performed, which showed a complete thrombosis in the iliac femoral arteries.Upon examination a gap between the 2 previously implanted stent was noted above the bifurcation level of the aorta, the stent had been crushed, elongated and migrated up into the abdominal aorta.Surgery was performed to removed it and an aorta-femoral bypass was implanted with 8mm of polytetrafluoroethylene.The expansion of the migrated stent was likely insufficient.The patient was discharged on the third postoperative day, there were no adverse patient sequela and no clinically significant delay reported.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,d6b: dates estimated.D4: the udi number is not known as the part and lot number were not provided.Literature attachment: article- a crushed and totally migrated iliac stent into the abdominal aorta look more carefully attached.Na.

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 investigation was unable to determine a conclusive cause for the reported stent migration, material deformation, stretched stent and patient-device incompatibility (wall apposition).A conclusive cause for the reported patient effect(s) of pain, occlusion, ischemia, thrombosis, diminished pulse pressure and the relationship to the product, if any, cannot be determined.The reported patient effects of pain, occlusion, ischemia, thrombosis, and surgical intervention are listed in the omnilink elite® vascular balloon-expandable stent system, electronic instructions for use (eifu) as known patient effects of coronary stenting procedures.The subsequent foreign body in patient and surgical 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: 16946999
• MDR Text Key: 315393998
• Report Number: 2024168-2023-05241
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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
• Date Manufacturer Received: 06/27/2023
• 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): Disability; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male