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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 ZVM10040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Thrombosis/Thrombus (4440)
Event Date 01/07/2022
Event Type  Injury  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent products are identified.Manufacturing review: the lot history record of this lot was 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 provided.Based on the information available, investigation is inconclusive for thrombosis/necrosis.A definite root cause of the reported incident cannot be identified based upon the available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risk.Based on the instructions for use, complications and adverse events associated with the use of the e-luminexx stent may include the usual complications associated with endovascular stent and covered stent placement which include "thrombosis at puncture site or remote site", "bleeding from anticoagulant or antiplatelet medications" and "embolization, distal (air, tissue or thrombotic emboli)".The instructions for use also states "the 6fr delivery system requires a minimum 6f introducer sheath.The delivery system has a soft and flexible catheter tip formed from the outer catheter.The catheter tip is tapered to accommodate a 0.035¿(0.89 mm) guidewire".The instructions for use further state: "after stent deployment, carefully withdraw the delivery system from the patient over the guidewire.After removing the delivery system, visually confirm that the entire stent delivery system has been removed.".
 
Event Description
It was reported that eighteen days post stent placement procedure through the iliac artery, the patient allegedly developed thrombus and the patient's fingertip became necrotic.The current status of the patient is unknown.
 
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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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13451369
MDR Text Key285049689
Report Number9681442-2022-00010
Device Sequence Number1
Product Code NIO
UDI-Device Identifier00801741147128
UDI-Public(01)00801741147128
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
Report Date 01/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberZVM10040
Device Lot NumberANDZ0961
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/07/2022
Initial Date FDA Received02/04/2022
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
Patient Outcome(s) Other;
Patient Age70 YR
Patient Weight45 KG
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