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

Catalog Number VENEM16080

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

Patient Problem Restenosis (4576)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified.As the lot number for the device was provided, a review of the device history record is currently being 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 instructions for use (ifu) is adequate for the reported device/patient code(s) 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.Expiry date: 10/2018.

Event Description

It was reported through the results of a clinical trial, that approximately seven months post index procedure, the subject developed high graded stenosis of left common iliac vein.Venovo stent was used to successfully treat the target lesion.The current patient status was not provided.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the venovo venous stent products that are cleared in the us.The pro code and 510 k number for the venovo venous stent products are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation and image was not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use sufficiently address the potential risk as the instructions for use states that venous occlusion/restenosis of the treated vessel is a potential complication or adverse event that may occur.Holding and handling of the delivery system during the procedure including accessories and preparation was found to be properly described.H10: d4 (expiry date: 10/2018), h11: h6 (method), 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 through the results of a clinical trial, that approximately seven months post index procedure, the subject developed high graded stenosis of left common iliac vein.Venovo stent was used to successfully treat the target lesion.The current patient status was not provided.

• Brand Name: VENOVO VENOUS STENT
• Type of Device: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12369455
• MDR Text Key: 268194697
• Report Number: 9681442-2021-00458
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VENEM16080
• Device Lot Number: ANAX2321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 11/19/2021
• 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
• Treatment: APIXABAN; APIXABAN; APIXABAN
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White