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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 VENUL20120
Device Problems Fracture (1260); Difficult to Remove (1528); Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2021
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 device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2022).Device not returned.
 
Event Description
It was reported that during stent placement procedure, the hcp allegedly felt resistance when retrieving the delivery system over the wire.It was further reported, a fluoroscopic images revealed that the stent allegedly fractured and elongated down the external iliac vein.Reportedly the stent was overlapped with another stent to expand.There was no reported patient injury.
 
Event Description
It was reported that during stent placement procedure, the hcp allegedly felt resistance when retrieving the delivery system over the wire.It was further reported, a fluoroscopic images revealed that the stent allegedly fractured and elongated down the external iliac vein.Reportedly the stent was overlapped with another stent to expand.There was no reported patient injury.
 
Manufacturer Narrative
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 sample was returned to the manufacturer 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 with heavy imprints and superficial damage which was considered an indication that the stent adhered to the stent brake during deployment.In addition, images were provided demonstrating the placed stent with elongation proximal of the position where the stent brake had been positioned (patient view) during deployment which may indicate that the elongation was caused in the section of the silicone brake.In summary, the investigation is confirmed for expansion issue, and elongation as subsequent event.The images could not confirm strut fracture and difficult removal.Based upon the available information a definitive root cause could not be determined.Labeling review: a review of the relevant instruction for use for this product was conducted.The instruction 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.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.
 
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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 Key11341726
MDR Text Key232379619
Report Number9681442-2021-00049
Device Sequence Number1
Product Code QAN
UDI-Device Identifier00801741103940
UDI-Public(01)00801741103940
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
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVENUL20120
Device Catalogue NumberVENUL20120
Device Lot NumberANEU4245
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2021
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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