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

Model Number 1012536-80

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was performed to treat a non-calcified external iliac artery.The 8.0x80mm absolute pro self-expanding stent system was advanced over a 018 command st guide wire via a bilateral access.During the deployment, the stent deployed about 3/4 then the thumbwheel stopped rotating.Force was applied to move the thumbwheel allowing the stent to fully deploy.The proximal end of the stent appeared to be invaginated.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6: device code 2017 - failure to follow steps / instructions.Visual and functional analysis was performed on the returned unit.The reported deployment difficulty, thumbwheel resistance and material deformation of the stent were unable to be confirmed due to the condition of the returned unit.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 of the reported lot revealed no other complaints reported from this lot.It should be noted that the absolute pro self-expanding stent system utilizes a 0.035¿ (0.89 mm) guide wire as indicated on the product label and in the instruction for use (ifu).Additionally, the absolute pro ifu states: use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.The investigation determined that the reported difficulties were likely the result of using an undersized guide wire with the absolute pro device.It is likely that inadequate support for the shaft due to use of an undersized guide wire caused restriction to the distal shaft lumens in the anatomy (possibly over the aortic bifurcation), preventing movement of the shaft lumens and causing the thumbwheel to lock up resulting in deployment difficulty.The chatter marks noted on the distal sheath and stent holder are consistent with the sheath being bent over a tight radius with insufficient guide wire support.Additional attempts to rotate the thumbwheel against resistance may have caused the noted tears/cracks to the outer member material.The reported deformation of the stent was likely the result of manipulation to the delivery system during the attempt to fully deploy the stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

Event Description

Subsequent to filing the initial report, the following additional information was received: the lesion was non-tortuous.Although there was no resistance noted, the absolute pro had to traverse through old partially occluded stents.No additional information was provided.

• 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: 10737790
• MDR Text Key: 213197576
• Report Number: 2024168-2020-08919
• 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: 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1012536-80
• Device Catalogue Number: 1012536-80
• Device Lot Number: 0040361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 018 COMMAND ST GUIDE WIRE