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

Model Number	VENUM16160
Medical Device Problem Codes	Fracture (1260); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent placement procedure in the external iliac, the stent allegedly exceeded the amount of time expected by the physician to release from the deployment catheter.There was no reported patient injury.
Additional Manufacturer Narrative
A voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
Additional Manufacturer Narrative
H10: a voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.H10: 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.However, images were provided for review.The investigation of the reported event is currently underway.H10: b5, d4 (expiry date: 05/2024), g3, h6 (device) h11: d4 (medical device lot number) 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 or Problem Description
It was reported that during a stent placement procedure in the common and external iliac vein via right common femoral vein, the stent allegedly exceeded the amount of time expected by the physician to release from the deployment catheter.It was further reported that upon removal of the delivery system, the stent was allegedly found to be fractured.There was no reported patient injury.
Additional Manufacturer Narrative
H10: a voluntary recall has been initiated for the venovo¿ venous stent system 9f which was product catalog/lot number specific.Reportedly the proximal end of the stent does not immediately expand upon deployment.The proximal end of the stent remains connected to the delivery system.As a result of the field action, this event is being reported as a malfunction reportable event.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 sample was not available for evaluation.A series of images were provided demonstrating that the stent was adhering to the inner catheter upon deployment but at the end fully expanded from the inner catheter.A stent fracture could not be identified.Based on the information available the investigation is closed with confirmed result for stent expansion issue.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 instructions for use was found to address potential worst case complications and adverse events potentially related to expansion issue such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: (expiry date: 05/2024).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 or Problem Description
It was reported that during a stent placement procedure in the common and external iliac vein via right common femoral vein, the stent allegedly exceeded the amount of time expected by the physician to release from the deployment catheter.It was further reported that upon removal of the delivery system, the stent was allegedly found to be fractured.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: 16567727
• Report Number: 9681442-2023-00086
• Device Sequence Number: 20224034
• Product Code: QAN
• UDI-Device Identifier: 00801741103612
• UDI-Public: (01)00801741103612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2023

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: VENUM16160
• Device Catalogue Number: VENUM16160
• Device Lot Number: ANGV0572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 04/28/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/20/2023; 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1897-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown