MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM

Catalog Number UNK LIFESTENT STENT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

No medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient with history of left lower extremity infections/wounds was scheduled for intervention.The right common femoral artery was accessed and an arteriogram was performed which demonstrated flush occlusion in the distal superficial/popliteal artery with reconstitution of the above-knee popliteal artery via multiple collaterals.The below-knee popliteal demonstrated multifocal mild to moderate narrowing and the origin of the anterior tibial artery was preocclusive.The tibioperoneal trunk, peroneal, and posterior tibial arteries were occluded.There was occlusion of the distal anterior tibial artery below the level of the dorsalis pedis with reconstitution via multiple collaterals.A 0.035 glidewire and angled catheter, the high-grade pre-occlusive narrowing of the proximal/mid sfa were traversed.Contrast injection demonstrated a dissection flap.Angioplasty of the proximal and mid sfa was performed and follow-up angiogram demonstrated persistence f the dissection flap.The decision was made to place a 5mmx150mm stent.The stent was deployed and angioplasty was performed using a 4mm balloon.Post angioplasty angiogram demonstrated a new dissection flap.A drug-coated balloon was used to treat the residual narrowing.Post angioplasty angiogram demonstrated persistence of the dissection flap.The decision was made to place a 5mm x 10cm stent spanning the area of dissection.The stent was post-dilated with a 5mm balloon.Post angioplasty angiogram demonstrated improved blood flow.A closure device was deployed in standard fashion.The patient tolerated the procedure well without immediate complication.

Event Description

It was reported through the results of a clinical trial that following stent placement in the left superficial femoral artery and popliteal artery, a dissection flap was noted.Angioplasty was performed with a drug-coated balloon and angiogram demonstrated persistent dissection flap.The decision was made to place a stent spanning the area of dissection.Post-stent angiogram demonstrated improved flow.The current patient status was not provided.

Event Description

It was reported through the results of a clinical trial that following stent placement in the left superficial femoral artery and popliteal artery, a dissection flap was noted.Angioplasty was performed with a drug-coated balloon and angiogram demonstrated persistent dissection flap.The decision was made to place a stent spanning the area of dissection.Post-stent angiogram demonstrated improved flow.The current patient status was not provided.

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: a physical sample was not returned, and images have not been provided.The reported event could not be re produced which led to an inconclusive evaluation result.Potential factors that could have led or contributed to the event reported have been evaluated.A device deficiency was not reported.Vessel dissection was identified after post dilation; an irregular strut configuration may have led to the reported dissection upon post dilation.An irregular stent placement may be caused by incorrect holding during deployment, or inadvertent movement of the hand.Insufficient or not performed balloon pre dilation may be a contributing factor.The dissection may also be related to repeated or inappropriate pta.In this case the lesion was pre dilated.Based on the information available a definite root cause for the event reported could not be identified.Labeling review: the lot number/ product code was not reported and a physical sample or image was not provided.A stent was implanted but it was not known which stent product was involved.The currently valid version of the vascular stent ifus were considered as relevant.Device holding and deployment as well as pre dilation were found addressed.

Event Description

It was reported through the results of a clinical trial that following stent placement in the left superficial femoral artery and popliteal artery, a dissection flap was noted.Angioplasty was performed with a drug-coated balloon and angiogram demonstrated persistent dissection flap.The decision was made to place a stent spanning the area of dissection.Post-stent angiogram demonstrated improved flow.The current patient status was not provided.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: g3 h11: h6(method) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: LIFESTENT STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8203661
• MDR Text Key: 131644374
• Report Number: 9681442-2018-00225
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LIFESTENT STENT SYSTEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention