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

Catalog Number 11005-39

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the left common iliac artery with heavy calcification.Pre-dilatation was performed using an armada 35 balloon without issues.The 9.0x39mm omnilink elite stent delivery system (sds) was deployed, however, the balloon got stuck in the 6french (f) sheath even after the balloon was deflated several times.The entire sheath with the wire and sds had to be removed.Due to longer manual compression and a compression bandage had to be applied, the patient had to lie down for 8 hours instead of 4-6 hours.Although there was a delay in the procedure, there was no adverse patient effect; hence no patient harm.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported difficult to remove was confirmed.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.The investigation was unable to determine a conclusive cause for the reported difficult to remove; however, factors that can contribute to difficult to remove include, but are not limited to, guiding catheter lumen obstructions, kinks, bends, procedural technique, insufficient support, or interactions with accessory devices.Based on the information provided and the condition of the returned device, a conclusive cause for the reported difficult to remove could not be determined; however, the observed deformation due to compressive stress (kinked shaft) and stretched shaft likely occurred while attempting to remove the device from the introducer sheath.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: 18387788
• MDR Text Key: 331493809
• Report Number: 2024168-2023-14378
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11005-39
• Device Lot Number: 3012441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• 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: 6F CORDIS