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

Catalog Number 11005-59

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 moderately tortuous and moderately calcified lesion in the left common iliac artery.A 9.0x59mm otw omni elite balloon expandable stent system (bess) was advanced through a 7f sheath; however, the bess was pulled completely out of the patient for control pictures and contrast.Slight resistance with the anatomy and the 7f sheath was felt.The bess was re-advanced, but while positioning the bess slight resistance with the 7f sheath and the anatomy was felt and the stent dislodged.The bess was removed and slight resistance with the 7f sheath and anatomy was felt.A cut-down was performed and the dislodged stent was removed.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned stent implant and the reported stent dislodgment was confirmed.The reported difficulty to advance and difficulty to remove through the sheath was unable to be confirmed due to the returned condition of the device.The reported difficulty to remove through the anatomy 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 similar incidents reported from this lot.There was no damage noted to the stent delivery system (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.A cine was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the media provided confirms that the stent was dislodged undeployed from the sds.The media confirms that the patient¿s anatomy is tortuous, which may have contributed to the event.The report states that the patient¿s anatomy was moderately calcified and moderately tortuous, which may be probably cause for the event.The media provided is not sufficient enough alone to determine if there were any device malfunctions, but it does not appear to show any visual malfunctions from this one image provided.Based on the reported information and cine review, the investigation determined the reported difficulty to advance, difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure.It is likely that the moderately tortuous and moderately calcified anatomy reduced the clearance of the sheath causing the reported resistance during advancement and retraction of the sds.Manipulation against resistance ultimately resulting in the stent dislodgement in the anatomy.Additionally, the treatment appears to be related to the operational context of the procedure as a cut-down was performed and the dislodged stent was removed delaying the procedure.The noted stent damages likely occurred during surgical stent removal.There is no indication of a product quality issue with respect to the design, manufacture.H6: device code 2017 removed.

• 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: 10854523
• MDR Text Key: 216849983
• Report Number: 2024168-2020-09625
• 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: 01/07/2021

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: 11/30/2022
• Device Catalogue Number: 11005-59
• Device Lot Number: 9062541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 7F RADIFOCUS® INTRODUCER II
• Patient Outcome(s): Required Intervention