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

Catalog Number VENEM14140

Device Problem Obstruction of Flow (2423)

Patient Problem Reocclusion (1985)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, dhr was performed and no manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.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 approximately two-year two-month post index procedure placement of stent, the target lesion (common and external iliac) was identified reoccluded.It was further reported that revascularization was performed and patient was hospitalized.The outcome of the event was resolved and recovered.

Manufacturer Narrative

H10: as the lot number for the device was provided, dhr was performed and no manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.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.H10: g4.H11: a1, b5, g1.H11:section a through f - the information provided by bd represents all of 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.

Event Description

It was reported through the results of a clinical trial that approximately one year post stent placement, re-intervention was performed with thrombectomy and placement of a bare metal stent.Approximately two years two months post index procedure, the target lesion was re-occluded.It was further reported that revascularization was performed and the patient was hospitalized.The outcome of the event was considered resolved.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Type of Device: VENOUS STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8822732
• MDR Text Key: 152079379
• Report Number: 9681442-2019-00137
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741102271
• UDI-Public: (01)00801741102271
• Combination Product (y/n): N
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2018
• Device Catalogue Number: VENEM14140
• Device Lot Number: ANAY0263
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APIXABAN.; APIXABAN.; APIXABAN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR