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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 VENUM12120
Device Problems Difficult or Delayed Positioning (1157); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
 
Event Description
It was reported that during a stent placement procedure in the left cephalic femoral vein, the stent allegedly failed to be deployed at the proximal end.It was further reported that after further rotation of the handle, the stent was released without any further complications.There was no reported patient injury.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2022).H11: d4 (medical device lot no), h6 (method).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.
 
Event Description
It was reported that during a stent placement procedure in the left cephalic femoral vein, the stent allegedly failed to be deployed at the proximal end.It was further reported that after further rotation of the handle, the stent was released without any further complications.There was no reported patient injury.
 
Event Description
It was reported that during a stent placement procedure in the left cephalic femoral vein, the stent allegedly failed to be deployed at the proximal end.It was further reported that after further rotation of the handle, the stent was released without any further complications.There was no reported patient injury.
 
Manufacturer Narrative
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 delivery system was returned for evaluation.The condition of the returned delivery system confirmed an expansion issue.The stent brake of the inner catheter which had been under the stent during deployment was found shifted to distal with heavy imprints, and superficial deformation which indicated that the stent adhered to the stent brake leading to breakaway and shifting upon removal, which leads to a confirmed result for expansion issue.Based on the information available the investigation is closed with confirmed 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: d4 (expiry date: 08/2022), g3.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.
 
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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
MDR Report Key11411196
MDR Text Key239140779
Report Number9681442-2021-00117
Device Sequence Number1
Product Code QAN
UDI-Device Identifier00801741103315
UDI-Public(01)00801741103315
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,health
Type of Report Initial,Followup,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVENUM12120
Device Catalogue NumberVENUM12120
Device Lot NumberANEV0591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2021
Date Manufacturer Received04/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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