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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM; VASCULAR AND BILIARY STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM; VASCULAR AND BILIARY STENT Back to Search Results
Catalog Number EX061703C
Device Problems Fracture (1260); Material Twisted/Bent (2981)
Patient Problem Injury (2348)
Event Date 07/19/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however,a photo and medical images were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).The catalog number identified has not been cleared in the us but is similar to the lifestent stent system that are cleared in the us.The pro code and 510k number for the lifestent stent system is identified.
 
Event Description
It was reported that sometime post endovascular stent placement procedure in superficial femoral artery, the patient allegedly had non-healing wound.It was further reported that through x-ray examination revealed the stent allegedly fractured resulting in obstruction of blood flow.The patient was stable.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing related root cause was considered; therefore, the lot history 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.Investigation summary: the device was not returned for evaluation.One digital copy of an x-ray was provided for evaluation.One single stent placed in the sfa of the patient could be seen, a twisted section of the stent could be confirmed.As the x-ray was taken without any contrast media the reported obstruction could not be verified.The reported stent fracture could not be verified.In this case, the lesion was pre dilated as well as post dilated; there were no reported difficulties during initial stent deployment and no deformation of the stent was identified right after stent placement.Based on the x-ray provided, the placed stent was confirmed to be twisted.The twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Based on the information available and the evaluation of the image provided, a definite root cause could not be determined.Labeling review: 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.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent stent system that are cleared in the us.The pro code and 510k number for the lifestent stent system is identified in d2 and g5.
 
Event Description
It was reported that sometime post endovascular stent placement procedure in superficial femoral artery, the patient allegedly had non-healing wound.It was further reported that through x-ray examination revealed the stent allegedly fractured resulting in obstruction of blood flow.The patient was stable.
 
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Brand Name
LIFESTENT 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 Key10394671
MDR Text Key202510778
Report Number9681442-2020-00192
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519001500
UDI-Public(01)04049519001500
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,foreig
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEX061703C
Device Lot NumberANEN0995
Was Device Available for Evaluation? No
Date Manufacturer Received09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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