MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG VENOVO VENOUS STENT SYSTEM

Model Number	VENUM16060
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.Medical device expiry date: 03/2021.
Event or Problem Description
It was reported that post stent placement at the bifurcation, the stent allegedly became stuck on another stent.Additional stents were implanted to open the area.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: review of manufacturing records was not performed, as no additional complaint has been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot 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: two digital x-ray copies were provided for evaluation.Both images show the two stents that were placed in left and right iliac veins.Based on the images, an entanglement respectively entrapment of the ends two stents that are located in the inferior vena cava could be confirmed.Whether this was due to incorrect placement of the stents or whether the stents moved during placement could not be determined based on these images.Based on the information available a definite root cause could not be identified.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 symptomatic iliofemoral venous outflow obstruction.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." potential complications and adverse events which may occur were found addressed, e.G.Malposition (failure to deliver the stent to the intended site), stent fracture or stent migration.
Event or Problem Description
It was reported that during simultaneous placement of two stents at the venous bifurcation, the stents allegedly became stuck to each other.Additional stents were implanted to open the area.There was no reported patient injury.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8786278
• Report Number: 9681442-2019-00094
• Device Sequence Number: 13963989
• Product Code: QAN
• UDI-Device Identifier: 00801741103568
• UDI-Public: (01)00801741103568
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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
• Operator of Device: Health Professional
• Device Model Number: VENUM16060
• Device Catalogue Number: VENUM16060
• Device Lot Number: ANDQ0158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR