MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011924-100

Device Problems Difficult to Remove (1528); Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat the common iliac artery with moderate calcification, moderate tortuosity and 85% stenosis.A 7fr sheath was placed and balloon angioplasty was performed with a 5x60 mm.035 balloon.The 9x100 mm absolute pro self expanding stent system (sess) was advanced to the lesion and deployment was initiated.There was resistance noted in the thumbwheel during deployment after about 25% of the stent was released.At this point it was noted the outer sheath of the stent separated into two pieces which caused the stent to become stuck in the artery and not moving.The hub of the sess was opened to physically unsheath the stent but this was not successful.The wheel was turned with some force and it became free.The entire sess including the stent was removed and the procedure was postponed for a later time.There were no adverse patient sequela.No additional information was provided.

• Brand Name: ABSOLUTE PRO .035 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: 18988043
• MDR Text Key: 338727839
• Report Number: 2024168-2024-03764
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08717648115295
• UDI-Public: (01)08717648115295(17)250930(10)2100361
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K072708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011924-100
• Device Lot Number: 2100361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2022
• 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
• Treatment: AMPLAZTER 035 COOK SHEATH
• Patient Outcome(s): Required Intervention