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

Catalog Number 11012-29

Device Problems Failure to Advance (2524); Malposition of Device (2616); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional omnilink elite stent delivery system is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat the subclavian artery with 95% stenosis.A 6fr sheath was used to deliver a 9.0x19 mm omnilink elite stent delivery system (sds); however, the stent dislodged and had to be retrieved via snare.Resistance was noted with the 6fr sheath prior to the dislodgement.Another 9.0x29 mm omnilink elite sds was attempted but it failed to cross the lesion and the stent was loose on the balloon.Resistance was noted with the 6fr sheath prior to the stent becoming loose on the balloon.To prevent another stent dislodgement, the stent was embedded into the vessel wall and the procedure was completed.No additional information was provided.

Event Description

It was reported that the procedure was to treat the subclavian artery with 95% stenosis.A 6fr sheath was used to deliver a 9.0x19 mm omnilink elite stent delivery system (sds); however, the stent dislodged and had to be retrieved via snare.Resistance was noted with the 6fr sheath prior to the dislodgement.Another 9.0x29 mm omnilink elite sds was attempted but it failed to cross the lesion and the stent was loose on the balloon.Resistance was noted with the 6fr sheath prior to the stent becoming loose on the balloon.To prevent another stent dislodgement, the stent was embedded into the vessel wall and the procedure was completed.Subsequent to the initially filed report the following information was provided: after the first stent dislodged an attempt was made to retain the guide wire and remove the sds but the length of the sds and guide wire didn't match so the sds could not be completely removed and the physician cut the shaft of the device.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported malposition of device and failure to advance could not be tested as they were based on operational circumstances.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 incidents.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment 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.H10: removed device code 2920.

• 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: 12759510
• MDR Text Key: 284447120
• Report Number: 2024168-2021-10022
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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: 11012-29
• Device Lot Number: 1021741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/11/2021
• Supplement Dates FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2021
• 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 SHEATH
• Patient Outcome(s): Required Intervention