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

Catalog Number 1011920-060

Device Problems Premature Activation (1484); Difficult to Advance (2920); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a 70% stenosed lesion in the superficial femoral artery (sfa).One unknown self-expanding stent was implanted, and a second stent was going to be placed proximally, with the stents overlapping.The 5.0x60mm absoluter pro self-expanding stent system (sess) was being advanced through the unspecified implanted stent but became caught and could not cross.The sess was removed, and it was noticed that the outer sheath moved by 2mm towards the handle of the system.Once outside of the anatomy, the physician decided to deploy the sess and found resistance with the locking mechanism and thumbwheel.Balloon dilatation was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported physical resistance/sticking - locking mechanism was unable to be confirmed.The reported premature activation and mechanical jam were able to be confirmed.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.The investigation determined the reported difficult to advance, premature activation, and mechanical jam appear to be related to circumstances of the procedure.It is likely that during advancement, interaction with the previously implanted stent resulted in the reported difficult to advance.Manipulation of the device and/or procedural contaminants likely compromised the device resulting in the confirmed resistance with the thumbwheel once removed from the anatomy; and thus resulted in the reported/noted premature activation (reported stent half-open state).The cause of the reported physical resistance / sticking with the locking mechanism was unable to be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 15879853
• MDR Text Key: 307274107
• Report Number: 2024168-2022-11985
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: HR
• 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,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011920-060
• Device Lot Number: 1100761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White