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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR STENT SYSTEM Back to Search Results
Catalog Number VIES08060
Device Problems Bent (1059); Positioning Failure (1158); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(b)(4).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 during a stent deployment procedure intended for the iliac artery with access through the femoral artery, the stent allegedly failed to deploy.Reportedly, a competitor's device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
A manufacturing review was performed.The lot history records have been reviewed with special attention to manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented that could have led to the event reported.No manufacturing anomalies or deviations, which may have caused or contributed to the event reported, have been identified.No additional complaint has been reported for this lot number previously.Investigation summary: based on the investigation of the returned catheter sample a deployment failure could be confirmed.The stent was found to be partially released and the metal rod was found to be bent which indicated that increased friction affected the delivery system during attempt of deployment.Upon investigation further deployment of the partially released stent was impossible.Potential factors that could have led or contributed to the reported event have been evaluated.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling applicable it was found that the instructions for use (ifu) sufficiently describe the potential issue.The ifu states: 'visually inspect the bard lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.(.) take care to avoid unnecessary handling, which may kink or damage the delivery system.', 'should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit.' and 'take care to avoid unnecessary handling, which may kink or damage the delivery system.'.
 
Event Description
It was reported that during a stent deployment procedure intended for the iliac artery with access through the femoral artery, the stent allegedly failed to deploy.Reportedly, a competitor's device was used to complete the procedure.There was no reported patient injury.
 
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Brand Name
LIFESTAR VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM   76227
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7135036
MDR Text Key95829909
Report Number9681442-2017-00308
Device Sequence Number1
Product Code NIO
UDI-Device Identifier04049519005935
UDI-Public(01)04049519005935
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
P080007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2018
Device Catalogue NumberVIES08060
Device Lot NumberANZK1816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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