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

Catalog Number 1012534-100

Device Problems Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

Medical device problem code 2017- against resistance manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional absolute pro vascular device referenced in b5 is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat an occluded lesion in the superficial femoral artery (sfa) with moderate tortuosity.The 6.0x100mm absolute pro self-expanding stent system (sess) was being advanced; however, some resistance was felt with the anatomy and the stent started to flower.The sess was removed without issues.A second 6.0x100mm absolute pro sess was advanced to the target lesion and was being deployed, however, the thumbwheel stopped working halfway through the stent deployment.The stent was partially deployed.The thumbwheel was pushed forward with force to attempt to fully deploy the stent but failed.The handle was opened and an attempt to deploy the stent was made but failed again.The stent was attempted to be pulled into the sheath but was unsuccessful and a cutdown had to be performed to remove the partially deployed stent.Nothing was left in the anatomy.There was prolonged hospitalization.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.Reportedly, the 6.0x100mm absolute pro sess was advanced to the target lesion and was being deployed, however, the thumbwheel stopped working halfway through the stent deployment.The stent was partially deployed.The thumbwheel was pushed forward with force to attempt to fully deploy the stent but failed.It should be noted the absolute pro vascular self-expanding stent system instructions for use (ifu) states: should unusual resistance be felt at any time, including resistance unlocking the handle or thumbwheel rotation, during either lesion access or 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.Although it was noted the physician used force in the attempts to deploy the stent, the force applied seemed to be a reasonable clinical response to the difficulties.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 during advancement interaction with the moderately tortuous and occluded anatomy resulted in preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.The treatment appears to be related to the operational context of the procedure as reportedly the handle was opened and an attempt to deploy the stent was made but failed again.The stent was attempted to be pulled into the sheath but was unsuccessful and a cutdown had to be performed to remove the partially deployed stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3: device returning updated from yes to no.E1: initial reporter updated.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 17981051
• MDR Text Key: 326238815
• Report Number: 2024168-2023-11656
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 1012534-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 GUIDE WIRE
• Patient Outcome(s): Required Intervention; Hospitalization