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

Catalog Number 11013-19

Device Problems Inflation Problem (1310); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Visual and functional analysis was performed on the return device.The device was returned with contrast on the balloon and in the inflation lumen.The balloon was tightly folded.There were crimp marks on the balloon and between the markers where the stent implant was initially crimped on.There was no damage noted to the balloon.The balloon inflated and held pressure with no anomalies noted; therefore, the reported inflation issue was not confirmed; however, as the stent was not received, the reported stent dislodgment 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 other complaints reported from this lot.Based on the information provided, a definitive cause for the reported difficulties could not be determined.It may be possible that the distal shaft of the omnilink elite was kinked or collapsed in the anatomy causing inflation difficulty resulting in stent dislodgment; however, this could not be confirmed.The additional treatment and minor surgical intervention to remove the stent were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion located in the subclavian artery.The omnilink stent balloon opened only at its proximal end, pushing the stent distally off the balloon.The balloon did not open on both ends at the same time.The stent was able be navigated, via catheter, to the superficial femoral artery, where it was successfully removed with minor surgical intervention.The patient remained stable.The stent was replaced by another omnilink to 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: 11003773
• MDR Text Key: 221488772
• Report Number: 2024168-2020-10442
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 11013-19
• Device Lot Number: 9060641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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