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

Catalog Number UNK ABSOLUTE PRO VASCULAR

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The location of the reported device was not provided; however, when information is received the investigation will be completed.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that an 8x60mm absolute pro vascular stent jumped during deployment.The stent was attempted to be pulled back, however this was unsuccessful and the stent remained implanted in the hypogastric artery.It is currently unknown if this was the intended area.Reportedly, post implantation, the top of the stent had kinked due to calcium.There was no adverse patient sequela reported.It was further reported by the physician that the absolute pro vascular stent is difficult to see compared to a non-abbott stent.No additional information was provided.

Manufacturer Narrative

D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.The lot history record for this product could not be reviewed and a similar complaint query could not be performed because the part and lot numbers were not reported.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal sheath was restricted or entrapped within the anatomy causing the stent to "jump" during deployment due to built-up tension within the shaft lumens of the delivery system resulting in a spring like release of the stent; however, this could not be confirmed.Reportedly the stent was kinked due to calcium.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: 9477490
• MDR Text Key: 175022015
• Report Number: 2024168-2019-14600
• Device Sequence Number: 1
• Product Code: NIP
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSOLUTE PRO VASCULAR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 01/11/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other