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

Model Number 1012535-80

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

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.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 similar 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 instruction for use states: use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.Based on the reported information, it is likely that inadequate support for the shaft due to use of an undersized guidewire 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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly calcified and tortuous lesion in the left superficial femoral artery (sfa).The 7.0x80mm absolute pro vascular self expanding stent system (sess) was advanced to the target lesion over a.014 non-abbott guide wire.During deployment, resistance was met with the thumbwheel and the stent could not be deployed.The decision was made to remove the sess however during retraction the stent partially deployed in the target lesion therefore the physician decided to continue with deployment.Resistance was still met rotating the thumbwheel however the stent was able to be completely deployed.There was no clinically significant delay in the procedure and no adverse patient effects.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11310975
• MDR Text Key: 232524143
• Report Number: 2024168-2021-01083
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176081
• UDI-Public: 08717648176081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012535-80
• Device Catalogue Number: 1012535-80
• Device Lot Number: 0012961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR