• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT Back to Search Results
Catalog Number ZVL14100
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Pain (1994)
Event Date 08/16/2021
Event Type  Injury  
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.The investigation of the reported event is currently underway.(expiry date: 06/2023).Device pending return.
 
Event Description
It was reported that during a stent deployment procedure, the white latch at the distal end was allegedly popped out by itself, leading to the failure of the stent to be released.The procedure was completed using another device.The patient experienced pain in leg and decreased oxyhemoglobin saturation; however, the current status of the patient is unknown.
 
Event Description
It was reported that during a stent deployment procedure, the white latch at the distal end was allegedly popped out by itself, leading to the failure of the stent to be released.The procedure was completed using another device.The patient experienced pain in leg and decreased oxyhemoglobin saturation; however, the current status of the patient is unknown.
 
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 in disassembled condition.The conversion tab was missing.It was not known why the grip was disassembled.Based on analysis of the returned sample, the investigation confirmed for detachment.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to 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'.Regarding stent placement precautions, the instructions for use states 'do not remove the white conversion tab (m) unless you have selected ¿the conventional method¿ for stent deployment'.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: 10/2023).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12457668
MDR Text Key271009932
Report Number9681442-2021-00502
Device Sequence Number1
Product Code NIO
UDI-Device Identifier00801741146602
UDI-Public(01)00801741146602
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
Report Date 10/06/2021
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 NumberZVL14100
Device Lot NumberANEX0549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/16/2021
Initial Date FDA Received09/11/2021
Supplement Dates Manufacturer Received01/24/2022
Supplement Dates FDA Received01/28/2022
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 Outcome(s) Other;
Patient Age54 YR
Patient SexFemale
-
-