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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT Back to Search Results
Model Number VENUM14160
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/08/2023
Event Type  malfunction  
Event Description
It was reported that during a stent placement procedure in external iliac vein via popliteal access, one of the leg of the stent allegedly failed to expand.It was further reported that the stent was able to expand after some maneuvers.There was no reported patient injury.
 
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.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.H10: d4 (expiry date: 08/2024).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.
 
Manufacturer Narrative
H10: this supplemental mdr is being submitted to report that mfr rpt# 9681442-2023-00211 was a duplicate record and was opened in error.The event details are being captured under complaint file #(b)(4) and was reported to the fda under mfr rpt# 9681442-2023-00213.H10: g3.H11: d4 (medical device lot number).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 : device pending return.
 
Event Description
It was reported that during a stent placement procedure in external iliac vein via popliteal access, one of the leg of the stent allegedly failed to expand.It was further reported that the stent was able to expand after some maneuvers.There was no reported patient injury.
 
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Brand Name
VENOVO VENOUS STENT
Type of Device
VENOUS 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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key17048666
MDR Text Key316400387
Report Number9681442-2023-00211
Device Sequence Number1
Product Code QAN
UDI-Device Identifier00801741103476
UDI-Public(01)00801741103476
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/07/2023
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 Model NumberVENUM14160
Device Catalogue NumberVENUM14160
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/08/2023
Initial Date FDA Received06/02/2023
Supplement Dates Manufacturer Received07/26/2023
Supplement Dates FDA Received08/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1897-2021
Patient Sequence Number1
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