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

Catalog Number 1012015-120

Device Problems Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/04/2024

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 a heavily calcified superficial femoral artery.The vessel was pre-dilatated with a 4.0x8mm armada 18 at 12 atmospheres and a 5.0x120mm armada at 12 atmospheres.The 6.0x120mm absolute pro self-expanding stent felt resistance during deployment as the thumbwheel would not turn after 3cm of the stent being deployed.During removal under fluoroscopy the device separated and some portion of the separated pieces were snared; however, another 6.0x80mm absolute pro was deployed over the separated pieces.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

• Brand Name: ABSOLUTE PRO LL 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: 19014318
• MDR Text Key: 339048885
• Report Number: 2024168-2024-03982
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648121739
• UDI-Public: (01)08717648121739(17)260630(10)3072562
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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 Catalogue Number: 1012015-120
• Device Lot Number: 3072562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2023
• 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: 61 YR
• Patient Sex: Male