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

Model Number VENUM14040

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 01/11/2021

Event Type  malfunction  

Event Description

During the recanalization of the ivc, plasty was performed first to 14mm, then 16mm, and finally to 18mm.Then given there was no adequate response, two kissing stents that were in common iliac vein and were ending in the distal ivc, wre continued with two 14mm venovo stents up to the infrarenal ivc.One of the stents deployed fine.The other stent, which was from the left side, did not deploy and remained constricted in the middle.Then the physician had to gently pass a 3mm low profile balloon and gradually dilated it in order to deploy correctly.Eventually it deployed.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 11257810
• MDR Text Key: 229656054
• Report Number: 11257810
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUM14040
• Device Catalogue Number: VENUM14040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2021
• Date Report to Manufacturer: 02/01/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 103