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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); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record 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: 05/2023).
 
Event Description
It was reported that during a stent placement procedure through puncture on femoral vein, the device was allegedly difficult to advance.It was further reported that under fluoroscopy, the stent was found to be opened at the tip.The device was removed and the inner tubing was found to be protruding around 1 cm.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 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.A device compatible pre-wetted guide wire could be advanced through the entire delivery system.The stent was prematurely deployed for a few mm.In this case, 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.Based on the returned sample analysis the investigation is closed with inconclusive result for 'difficult to advance' and confirmed for premature deployment.A definite root cause of the reported incident can not be identified.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'.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 (expiry date: 05/2023), 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 puncture on femoral vein, the device was allegedly difficult to advance.It was further reported that under fluoroscopy, the stent was found to be opened at the tip.The device was removed and the inner tubing was found to be protruding around 1 cm.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 Key11715063
MDR Text Key250605212
Report Number9681442-2021-00270
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 08/05/2021
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 NumberZVL14080
Device Lot NumberANES3489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Initial Date Manufacturer Received 03/29/2021
Initial Date FDA Received04/23/2021
Supplement Dates Manufacturer Received08/05/2021
Supplement Dates FDA Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
Patient Weight65
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