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

Catalog Number 1013015-150

Device Problems Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 01/31/2024

Event Type  malfunction  

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 performed to treat a lesion in the lower superficial femoral artery (sfa) with mild calcification and mild tortuosity.The 5.0x150mm absolute pro self expanding stent system (sess) was advanced to the lesion over a non-abbott 0.035 guide wire, and deployment was initiated.However, after deploying the stent approximately 5mm, the thumbwheel became stuck and could no longer be turned.The stent and delivery system were removed from the anatomy.Another same size absolute pro stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

B5 - describe event or problem: updated.The device was returned for analysis.The reported mechanical jam and the reported activation failure were able to be confirmed.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal shaft was bent in the mildly torturous and mildly calcified anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam and the reported activation/deployment failure.Interaction and/or manipulation of the device likely resulted in the noted device damages (sheath twisted/wrinkled, multiple jacket stabilizer, outer member and inner member bends) contributing to the reported difficulties.Further manipulation of the compromised device resulted in the noted handle damages (smashed proximal spool pegs, broken proximal spool peg).Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 18763612
• MDR Text Key: 336905460
• Report Number: 2024168-2024-02285
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648191572
• UDI-Public: (01)08717648191572(17)260930(10)3102662
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110028
• 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,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013015-150
• Device Lot Number: 3102662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2023
• 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 BOSTON SCIENTIFIC AMPLTAZ GUIDE WIRE