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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 ZVL14080
Device Problems Premature Activation (1484); Self-Activation or Keying (1557); Failure to Advance (2524); Device-Device Incompatibility (2919); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2021
Event Type  malfunction  
Event Description
It was reported that during a stent placement procedure in the lower extremity via a femoral venipuncture to treat deep venous thrombosis, great resistance was allegedly felt when the device was advanced over the guidewire.It was further reported that device could not reach the desired location and the device was attempted to be withdrawn when the stent allegedly got deployed prematurely.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
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.Expiration date: 02/2024.
 
Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiration date: 02/2024), g3 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 a stent placement procedure in the lower extremity via a femoral vein to treat deep venous thrombosis, great resistance was allegedly felt when the device was advanced over the guidewire.It was further reported that device could not reach the desired location and the device was attempted to be withdrawn when the stent allegedly got deployed prematurely.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during a stent placement procedure in the lower extremity via a femoral vein to treat deep venous thrombosis, great resistance was allegedly felt when the device was advanced over the guidewire.It was further reported that device could not reach the desired location and the device was attempted to be withdrawn when the stent allegedly got deployed prematurely.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 stent delivery system was returned for evaluation and photos were equally provided.Based on the analysis of the provided photos and the returned sample, the stent was partially deployed.A device compatible guide wire could be advanced through the entire delivery system.In this case, the customer reported that the device was flushed prior to use.Based on analysis of the provided photos and returned sample, the investigation is confirmed results for unintended partial deployment.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.With regards to device warning, the instructions for use states that "visually inspect the bard e luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage".Regarding preparation of the device the instructions for use states that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.Continue flushing until saline drips from the distal tip of the catheter (d) after flushing each luer port".Regarding accessories, the instructions for use states "the bard s.A.F.E.R 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" guidewire.With regards to indications for use, the instructions for use states that the stent is to be used on femoral and iliac arteries.Based on reported information, the intended placement site for this stent was the venous system which represents off-label use.H10: d4 (expiration date: 02/2024), g3, h6(device) 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.
 
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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 Key13050351
MDR Text Key282778585
Report Number9681442-2021-00633
Device Sequence Number1
Product Code NIO
UDI-Device Identifier00801741146596
UDI-Public(01)00801741146596
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 05/05/2022
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 NumberZVL14080
Device Lot NumberANFP3096
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2021
Initial Date FDA Received12/21/2021
Supplement Dates Manufacturer Received03/31/2022
05/03/2022
Supplement Dates FDA Received04/02/2022
05/07/2022
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
Patient Age70 YR
Patient SexFemale
Patient Weight55 KG
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