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

Catalog Number 1012014-150

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

Patient Problems Ischemia (1942); Embolism/Embolus (4438)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat femoral popliteal artery.The lesion was prepped with a 5mm balloon for 2 minutes at 10 atmospheres.The 5.0x150mm absolute pro self-expanding stent was partially deployed due to the thumbwheel noting resistance during deployment.The delivery system and the stent were removed under fluoroscopy.It was noted a.018 guide wire was used.The patient required popliteal bypass as complete thrombosis and distal embolization was noted.Ischemia at the leg was also noted.No adverse patient sequela was reported.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.2017: failure to follow instructions.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device (stent 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 did not indicate a lot specific quality issue.The reported patient effects of ischemia and embolism is listed in the absolute pro ll peripheral self-expanding stent system instructions for use (ifu) as a possible complication.Reportedly, a.018 guide wire was used.It should be noted the absolute pro ll peripheral self-expanding stent system ifu states: one 0.035¿ (0.89 mm) diameter guide wire.The deviation of the ifu appears to have caused/contributed to the reported difficulties.In addition, the partially deployed stent was removed from the patient with the delivery system.It should be noted the absolute pro ll peripheral self-expanding stent system ifu states: do not attempt to pull a partially-expanded stent back through the introducer sheath or guiding catheter.The stent is not designed for recapturing.Once the stent has started to deploy, it cannot be recaptured using the stent delivery system.Once the stent has started to deploy, it is not recommended to remove the stent with the delivery system.The deviation of the instructions for use appears to have caused/contributed to the reported patient effects.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 deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that use of the undersized 0.018¿ guidewire resulted in the noted device damages (sporadically bunched/wrinkled/pinched sheath, sheath drag marks, multiple jacket stabilizer bends/kinks, bunched jacket stabilizer) compromising the device resulting in preventing the shaft lumens from moving freely; thus resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.Further manipulation of the compromised device resulted in the noted torn jacket stabilizer with exposed inner braiding likely contributing to the reported difficulties.The reported difficulties and removing the partially deployed stent with the device possibly caused/contributed to the reported patient effects; however a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure as a femoral popliteal bypass was required.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 18449199
• MDR Text Key: 332162888
• Report Number: 2024168-2024-00207
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012014-150
• Device Lot Number: 2120561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2022
• 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): Hospitalization; Disability; Required Intervention