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

Catalog Number 1012014-150

Device Problems Difficult to Remove (1528); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Vascular Dissection (3160)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the superficial femoral artery with moderate calcification and moderate tortuosity.Pre-dilatation was performed with a 5x100 mm armada 35 percutaneous transluminal angioplasty (pta) catheter.The 5x100 mm absolute pro self expanding stent system (sess) was prepared per the instructions for use and then during deployment, the thumb wheel got stuck and was not moving forward.Therefore, the partially deployed stent and sess were removed slowly with resistance into the sheath and the complete system was taken out.During this part of the procedure, part of the iliac artery became dissected.An 8x40 mm absolute pro stent was implanted to treat the dissection.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.

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 reported patient effect of dissection is listed in the absolute pro ll peripheral self-expanding stent system instructions for use as a possible vessel use complication.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 interaction with the moderately calcified and moderately torturous anatomy and/or other devices resulted in restricting the shaft lumens from moving freely, thus preventing the thumb wheel from rotating and resulting in the reported mechanical jam and the reported activation/deployment failure.Interaction with the moderately calcified and moderately torturous anatomy and/or other devices during removal resulted in the reported difficult to remove.The reported difficulties possibly caused/contributed to the reported patient effect however a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9 - device available for eval updated from yes to no.H3 (reason device not evaluated by mfg) changed to na.

Event Description

It was reported that the procedure was to treat the superficial femoral artery with moderate calcification and moderate tortuosity.Pre-dilatation was performed with a 5x100 mm armada 35 percutaneous transluminal angioplasty (pta) catheter.The 5x100 mm absolute pro self expanding stent system (sess) was prepared per the instructions for use and then during deployment, the thumb wheel got stuck and was not moving forward.Therefore, the partially deployed stent and sess were removed slowly with resistance into the sheath and the complete system was taken out.During this part of the procedure, part of the iliac artery became dissected.An 8x40 mm absolute pro stent was implanted to treat the dissection.There were no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed reports, the following information was provided: it should be noted that the device is a 5x150 mm absolute pro sess.No additional information was provided.

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.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 interaction with the moderately calcified and moderately torturous anatomy and/or other devices resulted in restricting the shaft lumens from moving freely, thus preventing the thumbwheel from rotating and resulting in the reported mechanical jam and the reported activation/deployment failure.Interaction with the moderately calcified and moderately torturous anatomy and/or other devices during removal resulted in the reported difficult to remove.The reported difficulties possibly caused/contributed to the reported patient effect(s) however a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Although the difficulties encountered appear to be related to procedural circumstances, on (b)(6) 2022, abbott determined that a field safety notice (fsn) 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.H6: investigation findings code 4311 removed.

• 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: 12800314
• MDR Text Key: 284877222
• Report Number: 2024168-2021-10278
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 1012014-150
• Device Lot Number: 9121161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• 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: 0.035 GUIDE WIRE
• Patient Outcome(s): Required Intervention