Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 VENOVO VENOUS 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 VENOVO VENOUS STENT Back to Search Results
Catalog Number VENEM14080
Device Problems Misfire (2532); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
Manufacturer Narrative
A voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The catalog number identified has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified.(expiry date: 12/2022).
 
Event Description
It was reported that during stent deployment procedure, the proximal end of the stent allegedly failed to expand.It was further reported that the physician turned left and right with the catheter of the stent delivery system and the stent was deployed after two minutes.There was no reported patient injury.
 
Event Description
It was reported that during stent deployment procedure, the proximal end of the stent allegedly failed to expand.It was further reported that the physician turned left and right with the catheter of the stent delivery system and the stent was deployed after two minutes.There was no reported patient injury.
 
Manufacturer Narrative
H10: a voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.H10: 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 physical sample was not available, and images demonstrating stent or delivery system were not provided.The alleged issue could not be re produced which led to an inconclusive evaluation result.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instructions for use for this product was conducted.The instructions for use was found to address potential complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified in d2 and g4.H10: d4 (expiry date: 12/2022), g3.H11: h6 (method, result).H11: section a through f the information provide by bd represents all 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 : device not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VENOVO VENOUS STENT
Type of Device
VENOUS STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key11944696
MDR Text Key254559764
Report Number9681442-2021-00364
Device Sequence Number1
Product Code QAN
Combination Product (y/n)N
PMA/PMN Number
P180037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVENEM14080
Device Lot NumberANEZ3933
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberUNKNOWN
Patient Sequence Number1
Patient Outcome(s) Other;
-
-