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

Model Number	VENUL16060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient had benign superior vena cava syndrome, and approximately one year and eight months post stent placement, upon x-ray examination it was found that the implanted stent was allegedly fractured.It was further reported that x-ray examination showed that the fracture was right on that hinge in the stent.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 02/2021.Device pending return.
Event or Problem Description
It was reported that patient had benign superior vena cava syndrome, and approximately one year and eight months post stent placement, upon x-ray examination it was found that the implanted stent was allegedly fractured.It was further reported that x-ray examination showed that the fracture was right on that hinge in the stent.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the physical sample was not returned for evaluation.No images were provided for evaluation.The alleged issue could not be reproduced which leads to inconclusive evaluation result.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.The reported event represents an off label use.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describes holding and handling of the system throughout deployment; in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment.(.) do not hold or touch the dark moving sheath during stent release (.) '.The instructions for use further state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.' and 'post stent expansion with a balloon dilatation catheter is recommended.' stent fracture and occlusion were found mentioned under potential complications and adverse events.The venovo venous stent system is indicated for the treatment of symptomatic iliofemoral venous outflow obstruction.H10: (expiry date: 02/2021).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.

• Brand Name: VENOVO VENOUS STENT
• Common Device Name: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16535612
• Report Number: 9681442-2023-00077
• Device Sequence Number: 15034222
• Product Code: QAN
• UDI-Device Identifier: 00801741103636
• UDI-Public: (01)00801741103636
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: VENUL16060
• Device Catalogue Number: VENUL16060
• Device Lot Number: ANDZ0245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown