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

Model Number 1012534-100

Device Problems Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 03/10/2020

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.

Event Description

It was reported the procedure was performed to treat a lesion in the right external iliac artery.A 6x100mm absolute pro self-expanding stent system (sess) was advanced without resistance.The stent partially deployed but ultimately failed, so the sess was being removed when the stent fractured and separated.During removal, the stent interacted with unspecified previously deployed stents and was ultimately deployed in the left external iliac artery.An unspecified balloon was used to embed the stent and separated portion.There was 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 deployment issue, difficulty removing, and stent separation were unable to be confirmed due to the condition of the returned unit and the stent was not returned.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 complaints.The investigation was unable to determine a definitive cause for the difficulties.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
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9916746
• MDR Text Key: 187512797
• Report Number: 2024168-2020-03275
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 9080561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR