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

Model Number 1012623-39

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

The incident information was reviewed; however, the product was not returned to abbott vascular 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 similar incidents reported from this lot.The investigation determined the reported difficulties of difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure.Based on the reported information, the selected device size chosen for the procedure was too short to cover lesion.During retraction, the sds encountered resistance with the anatomy and/or other devices used causing the stent to dislodge on the wire.Manipulation during attempt to retrieve the stent using a snare device caused the stent to get stuck on the previously implanted stent.Additionally, the treatment appears to be related to the operational context of the procedure as a non-abbott covered stent was used to cover the entire area and embed the dislodged stent to the vessel wall.There is no indication of a product quality issue with respect to the design, manufacture.

Event Description

It was reported that the patient arrived emergently with a groin bleed from a previous procedure.The physician cut down to the femoral/popliteal artery to bypass directly.Imaging was taken and the bleed was visualized and an 8fr sheath was inserted to attempt bypass.A 7.0x39 mm omnilink elite stent was implanted without issue.An abdominal angiogram was performed and tight stenosis on the left iliac was noted.The physician called for another 7.0x39 mm omnilink elite stent and it was advanced up and over the iliac crest only on a guide wire as the sheath was only on the right side.Once the omnilink reached the lesion it was found that the stent was too short.During removal of the omnilink elite sds the stent dislodged and was not noted until the delivery system was pulled out.The stent remained on the guide wire.A snare was used to bring the stent to the right side; however, the stent became stuck on the previously implanted omnilink elite stent.A non-abbott covered stent was then used to cover the entire area and embed the dislodged stent to the vessel wall.There was a delay in the procedure.There were no adverse patient sequela.No additional information was provided.

• Brand Name: OMNILINK ELITE
• 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: 9845440
• MDR Text Key: 186761599
• Report Number: 2024168-2020-02569
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179266
• UDI-Public: 08717648179266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2020

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 Expiration Date: 08/31/2022
• Device Model Number: 1012623-39
• Device Catalogue Number: 1012623-39
• Device Lot Number: 9032641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• 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): Required Intervention
• Patient Age: 64 YR