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

Model Number VENUM20080

Device Problem Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being 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.(expiration date: 09/2022).

Event Description

It was reported that some time post stent placement, the stent allegedly bent.Reportedly, an additional procedure was required.The current patient status is unknown.

Event Description

It was reported that some time post stent placement the stent allegedly bent.Reportedly, an additional procedure was required.The current patient status is unknown.

Manufacturer Narrative

H10: 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 sample was not returned for evaluation.Based on the information available the investigation is closed with inconclusive result.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describe holding and handling of the system throughout deployment.In regards to pta the instructions for use states: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.', and 'post stent expansion with a balloon dilatation catheter is recommended.' h10: d4 (expiration date: 09/2022).H11: h6 (method).H11: section a through f - the information provided by bd represents all of 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
• Type of Device: VENOVO STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11853947
• MDR Text Key: 251823845
• Report Number: 9681442-2021-00323
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 00801741103858
• UDI-Public: (01)00801741103858
• Combination Product (y/n): N
• PMA/PMN Number: P180037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUM20080
• Device Catalogue Number: VENUM20080
• Device Lot Number: ANEW3424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention