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

Catalog Number UNK VENOVO STENT

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

A review was not performed because the lot number was not known.It was therefore not known whether the reported issue was potentially related to manufacturing.The stent delivery system was not available for evaluation; one image was provided demonstrating a released stent inside a vessel with irregular strut pattern and with blood flow which led to a confirmed result for deformation.Based on the information available a definite root cause for the reported event could not be determined.

Event Description

It was reported that during treatment, the stent allegedly failed to work as intended.There was no reported patient injury.

• Brand Name: UNKNOWN VENOVO STENT
• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10734769
• MDR Text Key: 213046024
• Report Number: 9681442-2020-00230
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2020

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 Catalogue Number: UNK VENOVO STENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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