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

Catalog Number 11005-39

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2020

Event Type  malfunction  

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 omni link device referenced is filed under separate medwatch report number.

Event Description

It was reported that during an iliac artery intervention, a 9x39mm omni elite balloon-expandable stent (bess) system was advanced in the 6f introducer against resistance but the stent system could be advanced to the lesion in the right iliac artery and the stent was deployed and implanted without issue.During removal of the stent delivery system, resistance was met with the non-abbott introducer sheath, so both devices were removed together.A second, 9x39mm omni elite bess met resistance when advancing through the 6fintroducer sheath to the left iliac artery.The device was removed without issue and another stent system was successfully advanced and implanted in the lesion without issue.There was no adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned stent delivery system (sds) and the reported difficulty to remove was confirmed.Additionally, the introducer sheath was noted to be stretched and jagged and the sds shaft was noted to be stretched.The reported difficulty to advance through the sheath was unable to be confirmed due to the returned condition of the device.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 reported from this lot.There was no damage noted to the sds during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to advance and difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information and returned analysis, it is likely that during advancement the anatomy and/or other device used, reduced the clearance of the sheath causing the reported resistance during advancement of the sds.Further manipulation against resistance during advancement likely caused the noted damages to the introducer sheath resulting in the difficulty to remove and subsequent stretch damages to the shaft during retraction.There is no indication of a product quality issue with respect to the design, manufacture.

• 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
• MDR Report Key: 11024570
• MDR Text Key: 225344010
• Report Number: 2024168-2020-10632
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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 Expiration Date: 06/30/2023
• Device Catalogue Number: 11005-39
• Device Lot Number: 0010941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1