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

Model Number 1012625-19

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

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.

Event Description

It was reported that the procedure was performed to treat a heavily calcified, moderately tortuous de novo femoral artery.The 9.0x19mm omnilink elite stent delivery system (sds) failed to cross due to the anatomy.Resistance was met with the sheath during withdrawal and the stent dislodged.The dislodged stent was retrieved with a snare.The procedure was completed with a new 8.0x19mm omnilink stent.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned stent and the stent dislodgement was confirmed.The reported difficulty to remove was unable to be confirmed due to the returned condition of the device.The reported failure to advance was unable to be replicated in a testing environment as it was 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 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 failure to advance, difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure.Based on the reported information, the stent delivery system (sds) encountered resistance with the anatomy resulting in the failure to advance, likely causing damage to the stent resulting in the difficulty to remove through the guiding catheter.Manipulation against resistance ultimately resulted in the stent dislodgement.The noted stent damages likely occurred during retraction with the snare device.Additionally, the reported treatment appears to be related to the operational context of the procedure as the dislodged stent was retrieved with a snare.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: 11013087
• MDR Text Key: 222078524
• Report Number: 2024168-2020-10531
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179327
• UDI-Public: 08717648179327
• 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: 02/10/2021

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 Expiration Date: 08/31/2023
• Device Model Number: 1012625-19
• Device Catalogue Number: 1012625-19
• Device Lot Number: 0031841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F MEDIKIT GUIDING CATHETER
• Patient Outcome(s): Required Intervention