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

Catalog Number 1012534-100

Device Problems Premature Activation (1484); Patient-Device Incompatibility (2682); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/23/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the right lower extremity with critical limb ischemia with gangrene and cellulitis of toes.The lesion was accessed with an 0.018 guide wire and a stiff micro puncture sheath and then a non-abbott guide wire and a 5fr sheath.Up and over access was performed and was somewhat challenging due to acute angles, mild tortuosity, and the presence of stents.It was possible to get down to the right distal external iliac artery; however, there was difficulty and a sparta core guide wire was able to get to the lesion so that balloon angioplasty could be performed to recanalize the present occlusion from above the knee popliteal artery to the entire superficial femoral artery using a 5x100 mm balloon.At this time the wire was exchanged back to a non-abbott 0.035 guide wire system and there was persistent stenosis at the adductor canal and diffuse atherosclerotic disease throughout the entire superficial femoral artery.It was attempted to place the 6x100 mm absolute pro self expanding stent system (sess), however, the deployment mechanism completely locked onto itself and the stent was unable to be deployed.The stent was backed over the wire into the sheath but during this process the stent un-sheathed and was deployed into the right aortofemoral bypass limb.There was no occlusion within the limb and the rest of the superficial femoral artery intervention was continued by placing a non-abbott 6x100 mm stent at the distal superficial femoral artery.At the proximal superficial femoral artery origin a 6x40 mm balloon expandable stent was used.At the proximal to mid segment another 6x100 mm absolute pro sess was deployed without issue.The stents were post dilated with a 6x100 mm balloon, including the absolute pro located in the aortofemoral limb.Subsequent angiogram showed improved lumen inflow through the superficial femoral and popliteal arteries.At the tibial segment, the anterior tibial artery was noted to have a short segment occlusion, likely from wire dissection by the non-abbott wire.A non-abbott guide wire and support catheter were used to advance a 2x40 mm balloon to angioplasty the proximal anterior tibial artery which showed recanalization.At this time it was decided to attend to the absolute pro stent in the right aortofemoral limb.The physician wanted to use a 10x100 mm stent to fix the undersized edges of the absolute pro stent; however, due to the anatomy, wire access was lost and could not be re-obtained despite ultrasound guidance.Therefore, the procedure was completed due to the length of the procedure, contrast use and patient tolerance.Ultimately the leg was amputated but this was due to the severe vascular disease and not the absolute pro stent.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 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.The reported premature activation and the reported patient-device incompatibility - wall apposition were unable to be replicated in a testing environment as it was 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 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 anatomy (which was reported as having acute angles, mild tortuosity, the presence of stents, persistent stenosis at the adductor canal and diffuse atherosclerotic disease throughout the entire superficial femoral artery) and/or manipulation of the device resulted in the noted smashed and bunched sheath and the noted kinked inner member preventing the shaft lumens from moving freely thus resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.Interaction/manipulation of the compromised device during removal resulted in the stent inadvertently deploying into the right aorto-femoral bypass limb resulting in the reported premature activation - unintended site and resulting in the reported patient-device incompatibility - wall apposition.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.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 17950582
• MDR Text Key: 325898475
• Report Number: 2024168-2023-11426
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012534-100
• Device Lot Number: 3032461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2023
• 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
• Treatment: GLIDEWIRE; SPARTACORE GUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 71 KG