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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 STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM; VASCULAR STENT Back to Search Results
Catalog Number EX090403C
Device Problems Positioning Failure (1158); Device Inoperable (1663); Misfire (2532)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2017
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 preparation of a stent placement procedure intended for the left iliac artery, it was observed the stent had allegedly self-activated.Reportedly, another device was used to perform the procedure.There was no patient contact.
 
Manufacturer Narrative
Further review of the file and based on the results of the investigation determined that the device was 1663 - device inoperable due to self-activation, rendering the device unusable.In addition, it was verified that the device did not partially deploy.However, since the initial mdr had already been submitted with partial deployment, this supplemental mdr will supersede this event from partial deployment to device inoperable.Since, device inoperable is not a reportable event, this event is being submitted as a not reportable event.Manufacturing review: a manufacturing review was performed.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 shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been previously reported for this lot number.Investigation summary: based on the investigation of the returned catheter sample it could be confirmed that the deployment mechanism was not actively used and that the system was not usable because it was self activated.Based on the information available and the sample evaluation, a definite root cause could not be determined.Labeling review: in reviewing the applicable labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states 'visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed.' (b)(4).
 
Event Description
It was reported that during preparation of a stent placement procedure intended for the left iliac artery, it was observed the stent had allegedly self-activated.Reportedly, another device was used to perform the procedure.There was no patient contact.
 
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Brand Name
LIFESTENT 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 Key7173506
MDR Text Key96952638
Report Number9681442-2017-00319
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519001845
UDI-Public(01)04049519001845
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Catalogue NumberEX090403C
Device Lot NumberANBT3782
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2017
Initial Date FDA Received01/08/2018
Supplement Dates Manufacturer Received01/24/2018
Supplement Dates FDA Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age62 YR
Patient Weight90
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