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

Catalog Number VENUM14120

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that during a stent placement, the device allegedly deployed partially and difficult to remove.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: d4 (medical device catalog).H11: section a through f: the information provide by bd represents all 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.H3 other text : device pending return.

Event Description

It was reported that during a stent placement through common and external iliac vein, the device allegedly failed to expand in the distal end and stent elongated.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the lot number was not reported, a review was not performed.Previous investigations of the similar complaints have been reviewed, and similar complaints were found.Investigation summary: the physical sample was not available, and images were not provided.The alleged issue could not be re produced which led to an inconclusive evaluation result.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant instructions for use for this product was conducted.The ifu was found to address potential complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H11: h6 (method, result).H11: section a through f: the information provide by bd represents all 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.H3 other text : device not returned.

Event Description

It was reported that during a stent placement through common and external iliac vein, the device allegedly failed to expand in the distal end and stent elongated.There was no reported patient injury.

• Brand Name: VENOVO VENOUS STENT
• Type of Device: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10982179
• MDR Text Key: 220695234
• Report Number: 9681442-2020-20070
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

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: VENUM14120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/11/2020; 04/06/2021
• Supplement Dates FDA Received: 01/07/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR