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

Catalog Number 11004-59

Device Problems Difficult to Remove (1528); Stretched (1601); Material Deformation (2976)

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

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure, as it is likely the balloon-expandable stent (bes) interacted with the 6f (french) sheath during retraction of the device causing the reported difficult to remove.Further interaction with the sheath caused the device to become stuck, ultimately stretching the stent, contributing the reported material deformation (flared stent struts).There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a mildly calcified, 50% stenosed lesion in the left external iliac artery.An 8x59mm omni elite balloon-expandable stent (bes) was advanced through a 6f (french) sheath, and advanced to the target lesion.Once at the lesion to be treated, it was noticed that the stent was too long for the lesion.An attempt was made to withdrawal the bes from the sheath; however, it became stuck and stretched with flared struts.The bes and the sheath had to be removed as a single unit.Guide wire (gw) access was maintained.There was no adverse patient effect and no clinically significant delay in the procedure.A new sheath and 7x39mm omnilink bes were used to successfully complete the procedure.No additional information was provided.

• 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: 13760269
• MDR Text Key: 287139930
• Report Number: 2024168-2022-02621
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11004-59
• Device Lot Number: 1042341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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: 6FR 11CM JOHNSON AND JOHNSON SHEATH
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 101 KG