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

Model Number	VENUM16160
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, image was provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2022).
Event or Problem Description
It was reported that during stent deployment through the right femoral vein via external iliac vein, the distal part of the stent allegedly had expansion issue.It was further reported that the physician manipulated the handle and the stent finally got opened.There was no reported patient injury.
Event or Problem Description
It was reported that during stent deployment in the iliac veins through femoral access, the proximal end of the stent did not expand.It was further reported that the physician rotated the handle and the stent finally expanded.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot history record of this lot was 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 physical sample was not available.One image was provided demonstrating the placed stent inside the iliac section.The stent is fully deployed but a sudden diameter decrease is visible in the section where the stent brake is located; distal and proximal of that section the diameter is increased which leads to confirmed result for 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 ifu 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.A definite root cause for the reported event could not be determined.H10: d4(expiry date: 10/2022), g3 h11: b5, h6(result) 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: VENOVO VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11626949
• Report Number: 9681442-2021-00212
• Device Sequence Number: 4022304
• Product Code: QAN
• UDI-Device Identifier: 00801741103612
• UDI-Public: (01)00801741103612
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/25/2021

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: VENUM16160
• Device Catalogue Number: VENUM16160
• Device Lot Number: ANEX1716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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