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

Model Number	VENUL14160
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2022).
Event or Problem Description
It was reported that during stent placement procedure, the stent failed to expand.The procedure was completed with same device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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: a physical evaluation was not performed because the sample was not available.Images have not been provided for evaluation.Based on the information available the investigation is closed with inconclusive 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.H10: b5, d4 (expiry date: 07/2022).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 bilateral venous stent placement, the stent failed to expand in the left iliac vein as the deployment system would not let go the stent.As reported the stent finally expanded from the system after slightly turning 2-5 minutes on the 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: 10873364
• Report Number: 9681442-2020-20036
• Device Sequence Number: 16859743
• Product Code: QAN
• UDI-Device Identifier: 00801741103544
• UDI-Public: (01)00801741103544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/27/2021

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: VENUL14160
• Device Catalogue Number: VENUL14160
• Device Lot Number: ANEU1595
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 03/29/2021
• 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