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

Catalog Number	VENUL16080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2025) 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.
Additional Manufacturer Narrative
H10: manufacturing review: 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 catheter sample is not available for evaluation.One provided x-ray image demonstrates the placed stent during post percutaneous transluminal angioplasty with radiopaque markers at one end, and another image demonstrates fractured stent end segments including markers with a disorder inside the vessel.A further image demonstrates bloody stent strut fragments outside patient.The investigation leads to confirmed result for stent strut fracture.It was not known when exactly during the procedure and why the stent fractured.The vessel was not tortuous, and the lesion was pre-dilated.The system was correctly held at the stability sheath, and kept stationary, and the user did not experience difficulty during deployment action.Based on the investigation of the provided information, the investigation is closed as confirmed for stent strut fracture.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended'.Under materials required the instructions for use state: '10f introducer for stent diameters of 16 mm, 18 mm and 20 mm ¿ 0.035 inch diameter guidewire'.Holding and handling of the system during deployment was found sufficiently described; in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment' and 'gently hold the stability sheath and maintain it straight and under tension throughout the procedure'.Stent fracture was found mentioned under potential complications and adverse events.H11: section a through f ¿ the information provided 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.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly fractured.It was further reported that the patient was treated with inserted forceps through a sheath to remove the fractured piece.There was no reported patient injury.

• 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: 20141251
• Report Number: 9681442-2024-00286
• Device Sequence Number: 7482427
• Product Code: QAN
• UDI-Device Identifier: 00801741103643
• UDI-Public: (01)00801741103643(17)250329(10)ANHQ2555
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Expiration Date: 03/29/2025
• Device Catalogue Number: VENUL16080
• Device Lot Number: ANHQ2555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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