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

Catalog Number 1011923-060

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device code 2017: failure to follow steps / instructions, excessive force.

Event Description

It was reported that the procedure was to treat a lesion in the right external iliac artery.The 8.00x60mm absolute pro self-expanding stent system (sess) was advanced to the target lesion and resistance was noted due to an unspecified stent that has been implanted in the common iliac artery (cia); however, the absolute pro stent was implanted without issue.The delivery system was removed from the patient and resistance was also noted also due to the unspecified stent implanted in the cia.After removal the tip of the sess was observed to have become separated.The tip was believed to be lodged in the right common femoral artery.No intervention was performed to remove the separated tip.There was no adverse patient sequela and no clinically significant delay reported in the procedure.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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.A cine was received and reviewed by an abbott vascular clinical specialist: based on the images provided it does appear that the tip of the device, and the proximal marker, were detached from the absolute pro stent delivery system post stent deployment.While there is no commentary or documentation as to the forces encountered upon removal of the absolute pro delivery system, the detachment of the absolute pro tip can occur when subjected to excessive withdrawal forces.Therefore it is reasonable to infer that excessive forces were applied to the absolute pro delivery system post stent deployment during retraction of the delivery system.The images suggest that the deployed absolute pro stent may have been compressed / shortened which supports the consideration that excessive forces was applied during delivery system withdrawal.It should be noted that the absolute pro.035 peripheral self-expanding stent system instructions for use (ifu) 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.As previous stated, for the absolute pro tip, as well as the proximal marker, to become detached, excessive force would need to be applied to the delivery system upon withdrawal, post stent deployment.While not reported, it is reasonable to presume that this occurred, and that the user failed to follow the ifu as to the proper mitigation techniques.Additionally, one cine image clearly shows both the delivery system markers, and an inflated balloon, on the same gw.For this to occur the absolute pro delivery system must have been removed with the detachment occurring at that time.There are no report details concerning any attempted removal of the detached component prior to this balloon delivery and inflation.Based on the distal movement of the proximal absolute pro marker it appears that the balloon was maneuvered distally, forcing the marker further distal.The gw was removed prior to the recovery of the detached component allowing free movement of the detached component.It should be noted that the absolute pro ifu states: if it is necessary to retain guide wire position for subsequent vascular or biliary access, leave the guide wire in place and remove all other system components.The deviations of the instructions for use appear 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 during advancement resistance was met with the previously implanted stent resulting in the reported difficult to advance.During delivery system removal interaction with the previously implanted stent resulted in the reported difficult to remove.Manipulation of the device resulted in the noted device damages (wrinkled sheath, kinked jacket, bent i-beam) and ultimately resulted in the reported tip material separation/noted inner member/distal sheath separations.As reported, the tip was believed to be lodged in the right common femoral artery and no intervention was performed to remove the separated tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.B2: outcomes attributed to ae e1: facility name, address, phone number updated h6: health effect - clinical code 3165 removed.

• 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: 16971048
• MDR Text Key: 315653065
• Report Number: 2024168-2023-05393
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011923-060
• Device Lot Number: 2050461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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): Disability; Other
• Patient Age: 84 YR
• Patient Sex: Male