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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 ZVL14100
Device Problems Premature Activation (1484); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2023).
 
Event Description
It was reported that during a stent placement procedure through femoral vein, during x-ray examination the stent allegedly protruded about 1cm from the tip.It was further reported that the device allegedly had resistance while passing.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
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.The inner catheter was seen protruding by a few mm and the stent was seen about 1mm partially deployed; one provided image demonstrates the partially deployed stent during tracking which leads to confirmed result for premature deployment.Neither images nor sample could confirm resistance during advancement.The device compatible introducer sheath was used and the system was flushed prior to use, however predilation was not performed.The intended placement of the device in the venous site represents an off-label use.Based on the evaluation the entire lumen of the stent delivery system could be flushed from the proximal luer port until liquid dripped from the distal end of the catheter.Pre-wetted guide wire freely moved through the entire sheath.The stent was found prematurely deployed which reasonably suggest to be an effect of the reported difficulties during advancement.Based on the returned sample analysis the investigation is closed as confirmed for premature deployment; difficulty to advance could not be confirmed.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.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'.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.' 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'.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'.With regards to system handling precautions, the instructions for use states 'the delivery system will not function properly until the safety clip is removed.As a precaution against accidental stent deployment, the safety clip should not be removed until the stent is ready to be deployed'.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 (expiry date: 06/2023), g3 h11: h6 (method, result, conclusion) 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.H3 other text : see h10.
 
Event Description
It was reported that during a stent placement procedure through femoral vein, during x-ray examination the stent allegedly protruded about 1cm from the tip.It was further reported that the device allegedly had resistance while passing.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 Key11676697
MDR Text Key245796627
Report Number9681442-2021-00233
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 07/30/2021
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 NumberZVL14100
Device Lot NumberANET2634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Initial Date Manufacturer Received 03/22/2021
Initial Date FDA Received04/16/2021
Supplement Dates Manufacturer Received07/30/2021
Supplement Dates FDA Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
Patient Weight60
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