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

Model Number 1012534-100

Device Problems Difficult to Remove (1528); Stretched (1601)

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

Event Date 08/17/2022

Event Type  Injury  

Event Description

User facility medwatch report received that states: describe the event or problem: doctor attempted to deploy an absolute pro vascular self-expanding stent 6f x 100mm x 135cm in the right superficial femoral artery (sfa).The distal end of the stent unraveled a considerable distance.The stent cannot be removed from the sfa so the surgeon balloon dilated the unraveled part of the stent to adhere it to the artery wall then placed additional stents to cover the unraveled stent segment and open up the sfa flow.What was the original intended procedure? : ultrasound-guided access of left common femoral artery.Left femoral angiogram.Aortogram with iliofemoral runoff.Right lower extremity angiogram.Selective catheterization of the right superficial femoral and popliteal arteries.Percutaneous stenting of the right mid external iliac artery with a 7 x 40 mm absolute pro self-expanding stent.Percutaneous rotational atherectomy of the right proximal to distal superficial femoral artery with the rotarex device.Retrieval of right superficial femoral artery foreign body.Percutaneous angioplasty of the right proximal to distal superficial femoral artery with standard angioplasty balloons.Percutaneous stenting of the right proximal to distal superficial femoral with 6 mm absolute pro uncovered and viabahn covered stents.Additional information was received that confirmed that the removal of foreign body was an unspecified device prior to placing the absolute pro stent.No additional information was provided.

Manufacturer Narrative

The device is not returning as it remains implanted in the patient.A follow-up report will be submitted with all additional relevant information.(b)(4).

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.Based on the limited details of the procedure the investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as reportedly additional stents were placed to cover the unraveled stent segment and open up the superficial femoral artery flow.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 15510678
• MDR Text Key: 300898635
• Report Number: 2024168-2022-10154
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

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: 10/31/2023
• Device Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 0111961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 100 KG