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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
Catalog Number 5F060801C
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2018
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the lifestent stent system products that are cleared in the us.The 510 k number and pro code for the lifestent stent system products are identified.No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently 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 during a stent placement for a calcified lesion in the distal sfa approximately 8cm in length, the stent allegedly foreshortened.The stent was used to overlap the first stent deployed.It was further reported the procedure was concluded with the two stent placements.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the lifestent stent system products that are cleared in the us.The 510 k number and pro code for the lifestent stent system products are identified.Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: stent delivery system was returned for evaluation.Based on the information available, the device sample and x-ray images provided the investigation for the reported stent foreshortening is closed with inconclusive result.Labeling review: the current labeling supplied with this product was reviewed.It was found that the instructions for use (ifu) sufficiently address the potential factor of inadequate deployment.The ifu states: "prior to and during stent deployment, remove slack from the delivery system catheter outside the patient by gently holding the stability sheath and keeping it straight and under tension." correct stent deployment is described in chapter e.4 stent deployment procedure/deploy stent.It is stated: "the second hand should be used to support the stent delivery system.Gently hold the stability sheath close to the introducer sheath and keep it stationary and under tension throughout deployment.Hold the green stability sheath.Do not hold or touch the brown moving sheath.".
 
Event Description
It was reported that during a stent placement for a calcified lesion in the distal sfa approximately 8cm in length, the stent allegedly foreshortened.The stent was used to overlap the first stent deployed.It was further reported the procedure was concluded with the two stent placements.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
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 Key7386962
MDR Text Key104045201
Report Number2020394-2018-00317
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741119996
UDI-Public(01)00801741119996
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2019
Device Catalogue Number5F060801C
Device Lot NumberANBU2821
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2018
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 Age61 YR
Patient Weight75
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