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

Catalog Number 1011915-080

Device Problems Premature Activation (1484); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional ht supra core device( referenced in b5 is filed under a separate medwatch report number.H6: medical device problem code 2017 - excessive force.

Event Description

It was reported that the procedure was to treat a mildly calcified, mildly tortuous superficial femoral artery that is less than 50% stenosed.The 6.0x80mm absolute pro self-expanding stent system (sess) was advancing over a supracore guide wire; however, resistance was noted between the devices before it entered the sheath valve outside the patient.The sess was retracted back about 10 centimeters to wet the wire with a wet raytec gauze and re-attempted to advance, but resistance was still noted.Therefore, the sess was attempted to be removed forcefully; however, the stent ended up fully deploying outside the patient on the guidewire during the attempt to remove the sess separately.Both devices were removed as one unit and a new supracore guide wire and new absolute pro stent was used to complete the procedure.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to advance and the reported difficult to remove were able to be confirmed.The reported premature activation was unable to be replicated in a testing environment due to the condition of the returned device (stent confirmed deployed).The inner member and tip jacket returned separated frozen over the guide wire with the tip remaining on the guidewire.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 6.0x80mm absolute pro self-expanding stent system (sess) was attempted to be removed forcefully; however, the stent ended up fully deploying outside the patient on the guidewire during the attempt to remove the sess separately.It should be noted the absolute pro.035 peripheral self-expanding stent system instructions for use (ifu), warnings section) states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement a coagulation of blood and/or contrast on the guide wire resulted in the reported difficult to advance and the reported difficult to remove over the guide wire.Manipulation of the device resulted in the noted wrinkled sheath (likely contributing to the reported difficulties), the noted separated inner member and tip jacket/tip and ultimately resulted in the reported/noted stent premature activation/deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Returned device analysis found that the inner member and tip jacket returned separated frozen over the guide wire with the tip remaining on the guidewire.No additional information was provided.

• 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: 17370900
• MDR Text Key: 319617802
• Report Number: 2024168-2023-07816
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072708
• 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,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011915-080
• Device Lot Number: 3032761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2023
• 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: SUPRACORE 190CM GUIDE WIRE