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

Catalog Number 1012014-150

Device Problems Difficult to Advance (2920); Activation Failure (3270); Noise, Audible (3273)

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

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

The device was returned for analysis.The reported activation failure and the reported noise were unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the very strong angulation and the highly tortuous anatomy resulting in the reported difficult to advance.Interaction and/or manipulation of the device resulted in the noted device damages (sheath chatter mark indentations and scratches, wrinkled sheath, kinked jacket stabilizer, outer member and inner member) resulting in preventing the shaft lumens from moving freely; thus resulting in the reported activation/deployment failure.Further manipulation in attempts to deploy the stent resulted in the reported noise/noted both proximal spool pegs smashed.The treatment appears to be related to the operational context of the procedure as reportedly the handle was disassembled in an attempt to fully deploy the stent and the device was removed from the anatomy and a non-abbott device was used to complete the procedure.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 a cross-over to treat the femoral artery with high tortuosity and very strong angulation.The 5x150 mm absolute pro self expanding stent system (sess) was difficult to advance to the lesion due to the anatomy but it made it to the lesion.When the stent was attempted to be deployed, the wheel was turned three times and a strange noise came from the handle.The mechanism then turned in the void.The stent partially deployed.The handle was disassembled in an attempt to fully deploy the stent.The device was removed from the anatomy and a non-abbott device was used to complete the procedure.There were no adverse patient sequela and there was no clinically significant delay in the procedure.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: 18979993
• MDR Text Key: 338619033
• Report Number: 2024168-2024-03675
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648130205
• UDI-Public: (01)08717648130205(17)260831(10)3092661
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012014-150
• Device Lot Number: 3092661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• 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
• Treatment: 0.035 ASAHI GUIDE WIRE
• Patient Outcome(s): Required Intervention