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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR STENT SYSTEM Back to Search Results
Model Number EX061503CS
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer, however, one photo was provided and is under review.The device has been returned for evaluation.The investigation is currently underway.The information provided by bard 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 bard.
 
Event Description
It was reported that after successfully placing the vascular stent in the sfa, during post dilation with a 150mm pta balloon, it was identified under fluoroscopy the vascular stent appeared to be allegedly longer than the pta balloon indicated.It was further reported that the stent functioned accordingly and remains in the patient.Reportedly, no further treatment was required.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a complete dhr review could not be performed as the lot number was unknown.Investigation summary: based on the investigation of the returned catheter sample and the provided image a stent elongation could not be confirmed.The delivery system was found in deployed state as reported; any abnormality indicating stent elongation or difficult deployment could not be identified.One image was provided including barely visible radiopaque scale; the stent length measured with this scale approximately matched the nominal stent length; the balloon against which the stent length was compared by the user was not visible on the image.In summary, the alleged stent elongation could not be re produced which led to an inconclusive investigation result.An indication for a process related issue could not be found.Based on the available information and the evaluation of the images provided, the investigation was inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the currently valid labeling for the vascular indication the potential issue was found addressed.The ifu states: 'confirm that the introducer sheath is secure and will not move during deployment.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 1 cm 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.' in regards to balloon dilation the ifu states: '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 after successfully placing the vascular stent in the sfa, during post dilation with a 150mm pta balloon, it was identified under fluoroscopy the vascular stent appeared to be allegedly longer than the pta balloon indicated.It was further reported that the stent functioned accordingly and remains in the patient.Reportedly, no further treatment was required.There was no reported patient injury.
 
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Brand Name
LIFESTENT VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key7501343
MDR Text Key107831305
Report Number9681442-2018-00056
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519001296
UDI-Public(01)04049519001296
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 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEX061503CS
Device Catalogue NumberEX061503CS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Date Manufacturer Received06/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
Patient Weight95
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