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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 ZVM07060
Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2022
Event Type  malfunction  
Event Description
It was reported that during the stent placement procedure of a highly calcified target lesion in the external iliac artery, the outer catheter allegedly got stuck with the calcified target and there was a strong resistance felt upon the stent was deploying.It was further reported that the outer catheter allegedly detached.Reportedly, the detached material was un retrievable so that another device was placed.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the e-luminexx vascular stent system products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent system products are identified.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 07/2024).Device not returned.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the e-luminexx vascular stent system products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent system products are identified in d2 and g4.H10: manufacturing review: 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 stent delivery system was not returned for evaluation and photos were not available for evaluation which leads to inconclusive results.It is only known that the target was highly calcified, and that strong resistance was felt upon deployment; pre-dilation was performed and was only indicated that the outer catheter that got detached.Based on the information available, the investigation is closed with inconclusive results.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding general warning, the instructions for use states "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".With regards to device warnings, the instructions 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".With regards to general directions, the instructions for use states "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".H10: d4 (expiration date: 07/2024).H11: section a through f: the information provide 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.
 
Event Description
It was reported that during the stent placement procedure of a highly calcified target lesion in the external iliac artery, the outer catheter allegedly got stuck with the calcified target and there was a strong resistance felt upon the stent was deploying.It was further reported that the outer catheter allegedly detached.Reportedly, the detached material was un retrievable so that another device was placed.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 Key16092866
MDR Text Key306657923
Report Number9681442-2022-00381
Device Sequence Number1
Product Code NIO
UDI-Device Identifier00801741146909
UDI-Public(01)00801741146909
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 01/10/2023
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 NumberZVM07060
Device Lot NumberANFU3060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2022
Initial Date FDA Received01/04/2023
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received01/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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