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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR AND BILIARY STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR AND BILIARY STENT SYSTEM Back to Search Results
Model Number EX071503CS
Device Problems Fracture (1260); Material Twisted/Bent (2981)
Patient Problem Thrombosis (2100)
Event Date 08/15/2018
Event Type  Injury  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
 
Event Description
It was reported that during an atherectomy procedure via sfa access with pre-dilatation, the stent was allegedly identified to be compressed after placement; therefore, a post-dilatation was performed.It was further reported that the patient was readmitted to the hospital later that day to treat a thrombosed leg as the stent allegedly fractured at the location of the compression identified during the initial procedure.Reportedly, a thrombectomy was performed and another device was deployed to cover the fractured stent.The patient was hemodynamically stable at the conclusion of the procedure.
 
Manufacturer Narrative
H10: manufacturing review: the lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: four x-ray images were provided.Based on the evaluation of the provided images a stent fracture could not be confirmed.However, the stent was found twisted in the middle section.Therefore the complaint will be confirmed for stent twisting.A manufacturing related issue could not be identified.Based on the information available and the evaluation of the images provided, a definite root cause could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu closely describes the stent placement by stating: 'to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.(.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position.(.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum.(.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.' the ifu also mentions balloon pre and post dilation: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.'.
 
Event Description
It was reported that during an atherectomy procedure via sfa access with pre-dilatation, the stent was allegedly identified to be compressed after placement; therefore, a post-dilatation was performed.It was further reported that the patient was readmitted to the hospital later that day to treat a thrombosed leg as the stent allegedly fractured at the location of the compression identified during the initial procedure.Reportedly, a thrombectomy was performed and another device was deployed to cover the fractured stent.The patient was hemodynamically stable at the conclusion of the procedure.
 
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Brand Name
LIFESTENT VASCULAR AND BILIARY STENT SYSTEM
Type of Device
VASCULAR AND BILIARY STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key8035530
MDR Text Key126068189
Report Number9681442-2018-00193
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519001326
UDI-Public(01)04049519001326
Combination Product (y/n)N
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX071503CS
Device Catalogue NumberEX071503CS
Device Lot NumberANCQ4693
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
Patient Weight77
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