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

Model Number	1012534-100
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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.Reportedly, a.014" size guide wire was used during the procedure.It should be noted that the absolute pro vascular self-expanding stent system instructions for use states: one 0.035" (0.89 mm) diameter guide wire.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.Additionally, it was reported that the thumbwheel got stuck on the third turn during deployment.The physician pushed back and forth on the thumbwheel and the wheel became unstuck.Turning was still difficult and the physician had to use force to turn the wheel.The stent was able to be deployed but when the physician looked at the deployed stent, a fracture was noted in the middle of the stent which separated in 2 pieces.It should be noted that the absolute pro vascular self-expanding stent system instructions for use states: should unusual resistance be felt at any time, including resistance unlocking the handle or rotating the thumbwheel, during stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment or deployment in an unintended location.The deviations of the instructions for use appears to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to deviations of the instructions for use and subsequent circumstances of the procedure as it is likely that use of the undersized.014¿ guide wire resulted in the distal shaft becoming bent/kinked by the heavily calcified and mildly torturous anatomy preventing the shaft lumens from moving freely; thus resulting in resistance with the thumbwheel and the difficulty deploying the stent.Manipulation of the device/thumbwheel using force ultimately resulted in the reported stent fracture/separation.The treatment appears to be related to the operational context of the procedure as reportedly the separated implanted stent was ballooned with a 6.0mm balloon post deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right superficial femoral artery (sfa) with heavy calcification and mild tortuosity.Atherectomy and pre-dilatation were performed.The vessel was prepared per instructions for use (ifu).The 6.0x100mm absolute pro self-expanding stent system (sess) was advanced without issue to the target lesion.However, the thumbwheel got stuck on the third turn during deployment.The physician pushed back and forth on the thumbwheel and the wheel became unstuck.Turning was still difficult and the physician had to use force to turn the wheel.The stent was able to be deployed but when the physician looked at the deployed stent, a fracture was noted in the middle of the stent which separated in 2 pieces.X-ray was used to verify the stent separation.The device was withdrawn without issue from the patient anatomy.The separated implanted stent was ballooned with a 6.0mm balloon post deployment.There was no harm to the patient.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 16512582
• Report Number: 2024168-2023-02443
• Device Sequence Number: 12341223
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 0072961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 GUIDE WIRE; 6FR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown