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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 ZVL14120
Device Problems Misfire (2532); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2023
Event Type  malfunction  
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2024).H11: section a through f ¿ the information provided by bd represents all 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 a stent placement procedure through right femoral artery, the stent was allegedly stuck at halfway and could not be released.It was further reported when the stent was withdrawn through ex vivo the stent delivery rod was allegedly bend.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during a stent placement procedure via the right femoral vein, the stent was allegedly stuck at halfway and could not be released.It was further reported that when the stent was withdrawn through ex vivo, the stent delivery rod was allegedly bent.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was not returned for evaluation but photos were provided showing a deformed catheter and a partially deployed stent which leads to confirmed results.It was reported that a 5f introducer with 0.018" guidewire were used for access, there was no calcification but the path was crooked and pre-expansion of the lesion was performed.Based on provided photos and available information, the investigation is closed with confirmed results for partial deployment and material deformation.A definite root cause for the reported event could not be determined.The intended placement of the device to treat iliac vein compression syndrome indicates off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to general warnings, the instructions for use states that "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".Regarding general directions, the instructions for use states "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".Regarding accessories, the instructions for use states "the bard safer 6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath" also "via the femoral route, insert a 0.035¿ (0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guide wire.The instructions for use states "the e-luminexx vascular stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery".H10: d4 (expiration date: 08/2024), g3.H11: b5, h6 (method, result, conclusion).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.
 
Manufacturer Narrative
Manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was returned for evaluation with the fully deployed stent as part of the sample.The delivery system was partially detached from the handgrip and a catheter deformation was found on the sheath proximal to the tip.It is not clear when the stent got fully deployed but the partial detachment of the delivery system from the handgrip is considered to have occurred as a result of manipulation post the reported event.The investigation leads to confirmed results for catheter deformation.Photos were provided showing a deformed catheter and stent fully deployed.It was reported that a 5f introducer with 0.018" guidewire were used for access, there was no calcification but the path was crooked and pre-expansion of the lesion was performed.Based on provided photos and the evaluation of the returned sample, the investigation is closed with confirmed results for material deformation.A definite root cause for the reported event could not be determined.The intended placement of the device to treat iliac vein compression syndrome indicates off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to general warnings, the instructions for use states that "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".Regarding general directions, the instructions for use states "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".Regarding accessories, the instructions for use states "the bard safer 6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath" also "via the femoral route, insert a 0.035¿ (0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guide wire.The instructions for use states "the e-luminexx vascular stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery".D4 (expiration date: 08/2024).H11: section a through f ¿ the information provided by bd represents all 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 a stent placement procedure via the right femoral vein, the stent was allegedly stuck at halfway and could not be released.It was further reported that when the stent was withdrawn through ex vivo, the stent delivery rod was allegedly bent.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
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18412107
MDR Text Key331540848
Report Number9681442-2023-00413
Device Sequence Number1
Product Code NIO
UDI-Device Identifier00801741146619
UDI-Public(01)00801741146619
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P080007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberZVL14120
Device Lot NumberANFV1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2024
Was Device Evaluated by Manufacturer? Yes
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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