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

Model Number VENUM16080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Injury (2348)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review was 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 instruction for use (ifu) is adequate for the reported device/patient 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.

Event Description

It was reported through the results of a clinical trial that at 24-month follow-up visit, intimal hyperplasia was identified via duplex ultrasound.No action is being taken at this time.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8616584
• MDR Text Key: 145270380
• Report Number: 9681442-2019-00066
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103575
• UDI-Public: (01)00801741103575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2017
• Device Model Number: VENUM16080
• Device Catalogue Number: VENUM16100
• Device Lot Number: ANAS2541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APIXABAN; ASPIRIN
• Patient Outcome(s): Other
• Patient Age: 64 YR