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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT -6F-ZVL 14/ 60/135
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT - MT -6F-ZVL 14/ 60/135 Back to Search Results
Catalog Number ZVL14060
Device Problems Break (1069); Positioning Failure (1158); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of sample is pending.The investigation of the reported event is currently underway.(expiration date: 06/2022).
 
Event Description
It was reported that during vascular stent placement procedure through inferior vena cava, the stent allegedly failed to deploy.It was further reported that the inner core of the stent delivery system might be allegedly fractured.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.However, the lot history records of this lot were 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 sample was returned to the manufacturer for evaluation.Based on the investigation of the returned sample it was confirmed that the user could not deploy the stent by using the trigger mode.The t-luer adapter was found detached from the grip which made a successful deployment using the trigger impossible, however, during evaluation testing the stent could be released using the pin and pull mode.The investigation will be confirmed for detachment.A definite root cause for the reported event could not be determined.The intended indication represents an off label use of the device.Labeling review: in reviewing the labeling it was found that the instruction for use sufficiently address the potential risks.Regarding the usage of a damaged product, the ifu states: "visually inspect the bard e-luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment." and "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 "the conventional method requires the user to remove the white conversion tab (m) before snapping the catheter out of the performaxx grip.The stent can then be deployed by using the conventional pin and pull-back technique." furthermore, the e-luminexx vascular stent is intended for use in the iliac and femoral arteries.H10: d4 (expiration date: 06/2022),g4.H11: h6(device, method,result and conclusion).H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that during vascular stent placement procedure through inferior vena cava, the stent allegedly failed to deploy.It was further reported that the inner core of the stent delivery system might be allegedly fractured.The procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
E-LUMINEXX VASCULAR STENT - MT -6F-ZVL 14/ 60/135
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key10584899
MDR Text Key208521747
Report Number9681442-2020-00203
Device Sequence Number1
Product Code NIO
UDI-Device Identifier00801741146589
UDI-Public(01)00801741146589
Combination Product (y/n)N
PMA/PMN Number
P080007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/20/2020
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 Catalogue NumberZVL14060
Device Lot NumberANDS4338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received09/25/2020
Supplement Dates Manufacturer Received11/16/2020
Supplement Dates FDA Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age59 YR
Patient Weight60
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