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

Model Number 1012534-60

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 03/17/2021

Event Type  Injury  

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 similar incidents and/or complaints reported from this lot.Images of the stent fracture was received.An abbott vascular medical affairs expert reviewed the details of the case and the angiographic images provided.Absolute pro stents (x2) were noted to have stent fractures.A single non dynamic image was sent with the review showing a picture of a stent.The image was not of high resolution.From the image provided it cannot be confirmed that there is a fracture within the stent struts.Multiple angle images of the stent would be helpful in determining any stent fractures as well as sending of the actual stents themselves.In conclusion, i could not confirm or deny a stent fracture from the single image provided in the report.Based on the information provided, a definitive cause for the reported stent fracture could not be determined.It may be possible that the open cell stent design of the absolute pro may give the appearance of a stent fracture; however, this could not be confirmed.The additional medical intervention was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other absolute pro vascular stent referenced is filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a lesion located in the left superficial femoral artery that was heavily calcified.An absolute pro vascular was deployed but a stent fracture was observed.Another absolute pro vascular stent was deployed but another stent fracture was observed.There was additional disease to treat so a third absolute pro was successfully deployed.A non-abbott stent was then deployed to cover the fractures of the first two stents that were deployed to complete the procedure.The patient is fine with no adverse patient sequela and no clinically significant delay.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11627884
• MDR Text Key: 244239579
• Report Number: 2024168-2021-02840
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175992
• UDI-Public: 08717648175992
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2021

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: 06/30/2022
• Device Model Number: 1012534-60
• Device Catalogue Number: 1012534-60
• Device Lot Number: 9072361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention