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

Model Number 1012531-80

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.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 calcified lesion in the iliac vessel.The 9.0 x 80 mm absolute pro self expanding stent system was advanced to the target lesion.During stent deployment, the deployment wheel stopped half way through deployment, but with manipulation the stent was able to completely deploy at the intended site.Post dilatation was completed successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported difficulties were unable to be confirmed as the stent was already fully deployed.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 revealed no other complaints reported from this lot.The investigation was unable to determine a definitive 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 chatter marks throughout the entire length of the distal sheath of the returned unit are consistent with the sheath being bent over an acute angle, further suggesting that anatomical conditions may have contributed to the difficulties encountered; however, this could not be confirmed.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: 11616405
• MDR Text Key: 245990586
• Report Number: 2024168-2021-02762
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175800
• UDI-Public: 08717648175800
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1012531-80
• Device Catalogue Number: 1012531-80
• Device Lot Number: 0031961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR