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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
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT Back to Search Results
Catalog Number ZVL12120
Device Problems Positioning Failure (1158); Misfire (2532); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 12/2022).
 
Event Description
It was reported that the physician found that the release trigger became loose before beginning to release the stent.Therefore the system was removed and the procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.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 delivery system the trigger was found in used condition and the stent was partially deployed which did not match the event description.It was not known when and how the stent deployment was initiated.The t-luer was found detached from the slide which was considered the alleged failure.The investigation will be closed as confirmed for detachment.An indication for a manufacturing related cause could not be found.Potential factors that could have led or contributed to the event reported were evaluated.Therefore, previous investigations of similar complaints were reviewed.During evaluation the t-luer was found detached.A difficult patient anatomy or a challenging placement site may lead to increased friction during deployment, and subsequent detachment.Exertion of high torque during system flushing, or damage caused by shipping or preparation may lead to damage and subsequent t-luer detachment upon use.In this case, the system was used in the iliac vein which is an off-label use.Based upon the available information a definitive root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risks.Regarding potential damages the instruction for use 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.'.In regards to accessories the instruction for use state: 'the bard e-luminexx vascular stent is only compatible with a 0.035¿ (0.89 mm) guidewire.' and 'the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath.' the product is indicated for use in the iliac and femoral arteries.H10: d4 (expiry date: 12/2022),.
 
Event Description
It was reported that the physician found that the release trigger became loose before beginning to release the stent.Therefore the system was removed and the procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
E-LUMINEXX VASCULAR STENT
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key11106980
MDR Text Key224863232
Report Number9681442-2020-20142
Device Sequence Number1
Product Code NIO
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 03/26/2021
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 NumberZVL12120
Device Lot NumberANDZ2614
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2020
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received03/27/2021
Supplement Dates FDA Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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