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

Catalog Number 1012014-120

Device Problems Difficult to Remove (1528); Stretched (1601); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

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

Event Date 04/16/2021

Event Type  malfunction  

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 did not indicate a lot specific quality issue.The investigation determined that the reported difficulties and subsequent treatment were likely due to case circumstances.It is likely that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation which was reported as heavily calcified with an acute angulation) preventing the shaft lumens from moving freely and preventing the thumbwheel from rotating resulting in partial deployment.The difficulty removing and stent stretching likely occurred due to removing the sess with the stent partially deployed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional absolute pro device referenced is filed under a separate medwatch report number.Na.

Event Description

It was reported that the procedure was to treat a heavily calcified, 10 centimeter (cm) long lesion in the superficial femoral artery.There was noted acute iliac bifurcation angulation.The 5x120 mm absolute pro self-expanding stent system (sess) was able to cross the lesion and the physician started deployment.After 1 cm, the thumbwheel stopped and it was not able to advance any more.The stent was not released more than 1 cm, therefore, the delivery system and the stent were removed together.Another 5x120 mm absolute pro sess was then advanced to the lesion and the system stopped after releasing half of the stent.It was attempted to pull but the stent could not be removed and then the stent was fully released.The stent covered the target lesion and was extended 2-3cm into some healthy tissue due to stretching from the pulling.Therefore, another absolute pro stent was used to treat the remaining portion of the lesion.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 11733812
• MDR Text Key: 247688780
• Report Number: 2024168-2021-03563
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 1012014-120
• Device Lot Number: 0021761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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