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

Model Number 1012530-80

Device Problem Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains implanted.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a procedure performed to treat a chronic total occlusion in the right iliac artery.Patient anatomy included two previously implanted stents.Pre dilatation was performed and an 8x80 absolute pro vascular stent was implanted without issue.A second absolute pro vascular stent was implanted proximally, overlapping the first stent, and routine post dilatation was performed.It was noted that the 8x80 stent appeared misshapen, as if it was bulging out and it was observed that a perforation occurred, with the stent extending outside the perforated artery.Massive hemorrhage was seen, and a non-abbott covered stent was implanted to seal the perforation; however, the bleeding continued.A dissection was noted outside the stented area.Prolonged balloon dilatation was performed, and the patient was air-lifted to a second facility.A surgical procedure was performed to repair the iliac artery.The non-abbott covered stent remained patent and no additional intervention was performed, related to the issue with the absolute pro vascular stent.Post surgical procedure, the patient was in stable condition.No additional information was provided.

Manufacturer Narrative

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 identified no other complaints.The reported patient effects of perforation and hemorrhage, as listed in the absolute pro instructions for use (ifu), are known possible adverse events that may be associated with the use of a stent in peripheral arteries and / or biliary tree.The investigation was unable to determine a cause for the reported difficulties.It may be possible that use of the larger diameter stent may have contributed to the difficulties reported including the misshapen appearance of the stent and the cascading patient effects that occurred after implant and post dilation.However, without having angiograms to evaluate, a definitive cause for the difficulties could not be determined.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: 9301474
• MDR Text Key: 165980937
• Report Number: 2024168-2019-13399
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175725
• UDI-Public: 08717648175725
• 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: 02/20/2020

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: 05/31/2021
• Device Model Number: 1012530-80
• Device Catalogue Number: 1012530-80
• Device Lot Number: 8062861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention