MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number 1012536-80

Device Problems Difficult or Delayed Positioning (1157); Material Separation (1562); Material Deformation (2976); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that the procedure was performed to treat a lesion with mild calcification in the left external iliac artery.An unspecified sheath,.035 guide wire and balloon were used for pre-dilatation.An 8.0 x 80 mm absolute pro vascular self-expanding stent was partially deployed when resistance turning the thumbwheel was noted.Fluoroscopy was difficult to see.Due to the significant amount of resistance, the physician held pressure on the thumbwheel and pulled back the device to remove the sheath.However, a small piece of the stent was noted to be sticking out and the stent implant separated at the access site.This caused a clinically significant delay as a surgeon was called to replace the sheath.The patient was transferred to surgery and a small cutdown was performed and the separated piece of the stent was removed successfully with no complications.The patient outcome was good and there were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported deployment issue and thumbwheel resistance could not be confirmed due to the condition of the returned unit.The poor visibility could not be confirmed.The stent damage and separation were 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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation) preventing the shaft lumens from moving freely and causing resistance with the thumbwheel.The damage noted to the distal sheath and chatter marks indicate that the shaft was possibly bent or entrapped over a tight radius during the attempt to deploy the stent.Additionally, it was reported that fluoroscopy was difficult to see.Fluoroscopy testing was performed on the returned unit and stent markers were visible, indicating that procedural conditions likely contributed to the poor visibility.The stent separation and extensive damage noted to the returned stent likely occurred due to withdrawing the delivery system into the sheath with the stent partially deployed.The additional surgery to remove the separated stent and delay in procedure were due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11269315
• MDR Text Key: 230007740
• Report Number: 2024168-2021-00813
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176166
• UDI-Public: 08717648176166
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1012536-80
• Device Catalogue Number: 1012536-80
• Device Lot Number: 9010761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 82