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

Model Number	VENUL14060
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 11/2022).
Event or Problem Description
It was reported that during a procedure, the device allegedly failed to deploy.There was no reported patient injury.
Event or Problem Description
It was reported, that during treatment the device allegedly, failed to deploy.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: he 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 returned delivery system was found with loaded stent and with activated wheel, but with loose joint slide block/ diving sheath.Which confirmed, that a deployment was impossible.The returned delivery system was found with loaded stent and with activated wheel, but with loose joint slide block/ diving sheath.Which confirmed, that a deployment was impossible.Potential factors that could have led or contributed to the event reported have been evaluated.Therefore, previous investigations of similar complaints were reviewed.In this case a force transmitting joint was confirmed being loose.Which caused the reported impossibility to deploy the stent.Based on evaluation of the stent delivery system returned, no indication for a manufacturing deficiency could be found.Based upon the available information a definitive root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: 'if excessive force is felt, during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit'.H10: d4(expiry date:11/2022).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.
Additional 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 returned for evaluation.The returned delivery system was found with loaded stent and with activated wheel but with loose joint slide block/ diving sheath which confirmed that a deployment was impossible.In this case a force transmitting joint was confirmed being loose, which caused the reported impossibility to deploy the stent.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use states: "if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit." h10: d4(expiry date:11/2022), g3 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.
Event or Problem Description
It was reported that during treatment the device allegedly failed to deploy.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: 11625966
• Report Number: 9681442-2021-00208
• Device Sequence Number: 17118105
• Product Code: QAN
• UDI-Device Identifier: 00801741103490
• UDI-Public: (01)00801741103490
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 05/26/2021

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: VENUL14060
• Device Catalogue Number: VENUL14060
• Device Lot Number: ANEY1245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 05/26/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/13/2021; 06/01/2021
• 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