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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 VENUM18080
Device Problems Fracture (1260); Misfire (2532); Detachment of Device or Device Component (2907); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 08/2022).
 
Event Description
It was reported that during a stent placement procedure, the distal portion of stent was allegedly fractured and would not allow for a full deployment.It was further reported that the distal portion remained in the vessel and the physician removed the broken stent and used new stent.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the lot history records 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 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.In this system compatible guidewire and introducer were being used, and the tracking vessel was straight.A pre dilation reportedly was not performed.Based on the information available and because no sample was provided for evaluation, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instruction for use state: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' in regard to damage, the instruction for use state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.Visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed.' in regard to pre dilation the instruction for use state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.' in regard to accessories the instruction for use state: '10f introducer for stent diameters of 16 mm, 18 mm and 20 mm (¿) 0.035 inch diameter guidewire' h10: d4 (expiry date: 08/2022),g3 h11: h6(device) 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.Device not returned.
 
Event Description
It was reported that during a stent placement procedure, the distal portion of stent was allegedly fractured and would not allow for a full deployment.It was further reported that the distal portion remained in the vessel and the physician removed the broken stent and used new stent.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
MDR Report Key11184703
MDR Text Key231584564
Report Number9681442-2020-20165
Device Sequence Number1
Product Code QAN
UDI-Device Identifier00801741103711
UDI-Public(01)00801741103711
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 01/22/2021
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 NumberVENUM18080
Device Catalogue NumberVENUM18080
Device Lot NumberANET0583
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/22/2020
Initial Date FDA Received01/18/2021
Supplement Dates Manufacturer Received06/21/2021
Supplement Dates FDA Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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