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

Model Number	VENUM18080
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during stent placement procedure, the proximal end of the stent allegedly twisted.There was no reported patient injury.
Event or Problem Description
It was reported that during stent placement on femoral vein via femoral to illic, the proximal end of the stent allegedly twisted and material deformed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the physical sample was not available.X-ray images were provided demonstrating the placed stent inside the vessel.The stent was expanded with minor constriction in the od towards the distal end (patient view) and with minor strut irregularity which leads to a confirmed result for deformation.A twisting was not visible.The images could not confirm an expansion issue.A definitive root cause could not be determined based upon the available information.Labeling review: a review of the relevant instruction for use for this product was conducted.The instruction for use 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.H10: g3 h11: h6 (method, results) 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.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
• MDR Report Key: 11336469
• Report Number: 9681442-2021-00046
• Device Sequence Number: 10996533
• Product Code: QAN
• UDI-Device Identifier: 00801741103711
• UDI-Public: (01)00801741103711
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: VENUM18080
• Device Catalogue Number: VENUM18080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 63