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

Catalog Number 1012014-150

Device Problems Device Dislodged or Dislocated (2923); Activation Failure (3270); Noise, Audible (3273)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/06/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous lesion in the distal superficial femoral artery (dsfa).During a cross-over procedure, a 5.0x150mm absolute pro ll self-expanding stent system (sess) was advanced to the target lesion and approximately 15mm of the stent was deployed when a clicking sound was heard and the thumbwheel moved freely without further deployment of the stent.An attempt was made to retract the stent, which dislodged the stent from the delivery system into the distal to proximal sfa up into whole common femoral artery (cfa).The stenting was prolonged, and the stent was not expanded, therefore the stent was embedded into the vessel to achieve proper blood flow.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.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.

Manufacturer Narrative

The device was returned for analysis.The outer member was separated from the shuttle, where the separated outer member located distal to the handle (remained in one piece).The distal end of the handle was scratched.The thumbwheel spool and a separated spool portion were loose inside the handle halves.The reported activation failure and the reported device dislodged or dislocated was unable to be replicated in a testing environment due to the condition of the returned device.The reported noise was able to be confirmed.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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the heavily calcified, mildly tortuous anatomy prevented the shaft lumens from moving freely resulting in the reported activation failure/difficulty deploying the stent.Manipulation of the device in attempts to deploy the stent likely resulted in the noted multiple device damages; thus resulting in the reported/noted thumbwheel noise and ultimately resulted in the reported stent dislodgement.The treatment appears to be related to the operational context of the procedure as reportedly the stent was embedded into the vessel to achieve proper blood flow.On may 11th, 2022, abbott determined that a field safety notice was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks.

Event Description

Subsequent to the previously filed report, the corrected information was provided: an attempt was made to retract the stent, which dislodged the stent from the delivery system into the distal to proximal sfa up into whole common femoral artery (cfa).The stenting was prolonged, and the stent was not expanded, therefore the stent was embedded into the vessel to achieve proper blood flow.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.

• 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: 16843925
• MDR Text Key: 314284048
• Report Number: 2024168-2023-04491
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 06/07/2023
• 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
• Treatment: CORDIS EMERALD 0,035" 260 CM WITH J-TIP
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 100 KG