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

Model Number	VENUL16100
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the physical sample was not available, and images demonstrating stent or delivery system were not provided.The alleged issue could not be re produced which led to an inconclusive evaluation result.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 complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.Device not returned.
Event or Problem Description
It was reported that during a stent placement procedure, the distal third of the stent deployed; however, the healthcare professional had to use a separate guide wire and balloon to complete expansion and to get the stent detached from the delivery system.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
• MDR Report Key: 12428284
• Report Number: 9681442-2021-00490
• Device Sequence Number: 4264754
• Product Code: QAN
• UDI-Device Identifier: 00801741103650
• UDI-Public: (01)00801741103650
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 08/11/2021

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: VENUL16100
• Device Catalogue Number: VENUL16100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1