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

Catalog Number 1013016-150

Device Problems Break (1069); Material Separation (1562); Material Deformation (2976); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/29/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat an 80% stenosed de novo lesion in the superficial femoral artery (sfa) with mild calcification and mild tortuosity.The 6.0x150mm absolute pro self expanding stent system (sess) was advanced to the target lesion to treat arterial disease of the lower extremities.When attempting to deploy the stent, only 3-4 cm of the stent was able to be released.Although the thumbwheel advanced without issue, only 30% of the stent could be implanted.The sess was attempted to be removed from the patient, but the stent separated and the distal end of the stent remained in the vessel.Outside the patient anatomy, the portion of the stent that was able to be removed was noted to have twisted stent struts.Antegrade puncture was performed and a small balloon was advanced in an attempt to remove the separated portion of the stent; however, this was not successful.The separated portion remained implanted in the vessel outside the target lesion, and the patient is in stable condition.Another absolute pro stent was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported stent damages (material deformation, material separation, break) were unable to confirmed as the stent was not returned.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.As there was no damage noted to the device during the inspection prior to use, it is possible that the distal shaft was bent in the mildly calcified, mildly tortuous and 80% stenosed anatomy and/or interaction with other devices resulted in preventing the shaft lumens from moving freely resulting in the reported activation/deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation/deployment failure cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.A cine was received and reviewed by an abbott vascular clinical specialist: it was reported that an absolute prosess experienced a fracture and subsequent separation of the distal portion of the stent in the sfa.The returned device was reported as having several defects including a kink at the distal end of the sheath, a crack in the handle, damaged spool axle and separated inner member.There was bunching distal to the outer member of the device for 2 mm.The handle was cracked open when received for evaluation.It is not clear if the damage was a result of the delivery, attempted deployment, and retraction of the device or if it occurred after removal of the device or during the return shipment.It is assumed that damage of this extent would be noted prior to insertion.The images provided show the device during attempted deployment.No kink is seen in the shaft of the device.It is noted that the stent is not fully deployed and a fracture is clearly noted.The probable cause for the failed deployment and subsequent stent fracture could not be identified.

• 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: 18591771
• MDR Text Key: 333894332
• Report Number: 2024168-2024-01130
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110028
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013016-150
• Device Lot Number: 3092761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• 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
• Patient Outcome(s): Required Intervention