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

Model Number 1012534-60

Device Problems Malposition of Device (2616); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 incidents from this lot.It is possible that interaction with the 80% stenosed lesion and/or the device was bent in the anatomy preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported physical resistance/sticking-thumbwheel cannot be determined.Manipulation of the compromised device and/or interaction with the 80% stenosed lesion likely resulted in the reported malposition of device (stent jumped when deployed).There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat an 80% stenosed lesion in the left common iliac artery.The 6.0x60mm abs pro self-expanding stent system (sess) was advanced to the target lesion and resistance was noted with the advancing the thumbwheel during deployment while retracting the sheath.The stent flowered; however, the stent jumped when deployed.The stent deployed partially in the target lesion and partially in healthy tissue.Another absolute pro stent was deployed to cover the additional area of the lesion that was not covered by the initially deployed stent.There was no adverse patient effect and no clinically significant delay reported in the procedure.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: 17232006
• MDR Text Key: 318195818
• Report Number: 2024168-2023-06969
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012534-60
• Device Catalogue Number: 1012534-60
• Device Lot Number: 2121561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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