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

Catalog Number 1013016-120

Device Problems Break (1069); Patient-Device Incompatibility (2682); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Ischemia (1942)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in patient.The device will not be returned for evaluation.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 to treat a heavily calcified superficial femoral artery.A 6.0x120mm absolute pro ll was advanced to the lesion with resistance met with the anatomy.After stent deployment, it was noted that the stent [collapsed] and the distal part of the stent was fractured but not in two pieces.Poor wall apposition was noted.Blood flow was reduced.The physician used a non-abbott balloon to dilate the stent.There was no adverse patient sequela reported.

Manufacturer Narrative

The device was not returned for analysis.The reported patient effect of ischemia is listed in the absolute pro ll instruction for use as a known potential adverse event.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 similar incidents from this lot.An abbott vascular medical affairs expert reviewed the details of the case and the angiographic images provided.The distal stent of the absolute pro ll 6.0 x 120 mm is stretched, and the marker beads of the distal stent indicate that there is some twisting of the stent.The probable cause is undetermined but pulling back on the whole system during deployment can contribute to this type of deployment.There are no images of the full deployment to confirm.The investigation was unable to determine a cause for the reported stent damage during deployment causing poor wall apposition and reduced blood flow.It may be possible that the delivery system was moved or repositioned during deployment causing the stent to stretch, fracture and/or twist in the vessel; however, this could not be confirmed.The reported resistance during advancement was likely due to the challenging anatomy, which was described as heavily calcified.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: 9140176
• MDR Text Key: 161309444
• Report Number: 2024168-2019-12244
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 1013016-120
• Device Lot Number: 9041761
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention