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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT SYSTEM Back to Search Results
Catalog Number VENEM12100
Device Problems Misfire (2532); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2019
Event Type  malfunction  
Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The catalog number identified has not been cleared in the u.S.But, it is similar to the venovo venous stent system products that are cleared in the us.The 510 k number and pro code for the venovo venous stent system products are identified.(expiry date: 02/2021).
 
Event Description
It was reported that during stent placement via a calcified tracking vessel, the stent allegedly partially deployed as the healthcare provider could not move the thumb wheel any further; it was further reported that another delivery system was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during stent placement via a calcified tracking vessel, the stent allegedly partially deployed as the healthcare provider could not move the thumb wheel any further; it was further reported that another delivery system was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: based on the evaluation of the sample returned, no manufacturing related issue could be identified.A manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.However, the lot history records have been 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: based on device sample returned for evaluation and the x-ray copies provided, it could be confirmed that the distal end of the stent was missing, while more than half of the stent length were still loaded inside the delivery systems catheter.The condition of the delivery system indicates that increased forces were applied on the system, most likely during an attempt to deploy the stent.In addition, the delivery system handle was found disassembled and parts were missing, which made it impossible to reproduce the initial failure that may have caused the reported issue.Based on the evaluation completed, no manufacturing related issue could be identified.As a result of the investigation performed the reported partially deployment is confirmed.However, based on the information available and the evaluation of the sample returned a definite root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential risks and the correct use of the device.The ifu states that the venovo¿ venous stent system is indicated for the treatment of stenoses and occlusions in the iliac and femoral veins.Regarding deployment the ifu states: "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." regarding accessories the ifu states that the following standard materials may be required to facilitate delivery and deployment of the venovo¿ venous stent system: 8f introducer for stent diameters of 10 mm and 12 mm; 9f introducer for a stent diameter of 14 mm; 10f introducer for stent diameters of 16 mm, 18 mm and 20 mm and 0.035 inch (0.89 mm) diameter guidewire.The holding and handling of the device during preparation and deployment were found sufficiently described.The catalog number identified has not been cleared in the u.S.But, it is similar to the venovo venous stent products that are cleared in the us.The 510 k number and pro code for the venovo venous stent products are identified.
 
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Brand Name
VENOVO VENOUS STENT SYSTEM
Type of Device
VENOUS STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key8725300
MDR Text Key148942261
Report Number9681442-2019-00079
Device Sequence Number1
Product Code QAN
UDI-Device Identifier00801741102103
UDI-Public(01)00801741102103
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
Type of Report Initial,Followup
Report Date 10/18/2019
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 Expiration Date02/22/2021
Device Catalogue NumberVENEM12100
Device Lot NumberANDP3953
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Initial Date Manufacturer Received 05/28/2019
Initial Date FDA Received06/21/2019
Supplement Dates Manufacturer Received10/01/2019
Supplement Dates FDA Received10/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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