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

Model Number	VENUM14100
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
Event or Problem Description
It was reported that during a stent placement procedure, the stent was allegedly failed to deploy.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure correctly, the stent was allegedly failed to deploy.There was no reported patient injury.
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 physical sample was not available, and images have not been provided which led to inconclusive evaluation result.Potential factors that could have led or contributed to the reported event have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.Poor information was provided about the event; a detailed failure description was not provided.Deployment failure may be related to difficult patient anatomy or challenging placement site.Inadequate accessories used, missing pre dilation, damage caused during transport, unpacking, or preparation may be contributing factors.In this case indication, placement site, patient condition, and procedural details were not reported.Based on the information available and because no sample was provided for evaluation, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' regarding pta the instructions for use state: 'predilation of chronic lesions with a balloon dilatation catheter is recommended.' the instructions for use also state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.' holding and handling of the system throughout the procedure including unpacking, preparation, and accessories to be used was found addressed in the instructions for use.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: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2022), h11: d4 (medical device lot).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 pending return.
Event or Problem Description
It was reproted that during a stent placement procedure, the stent was 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: 11264467
• Report Number: 9681442-2021-00007
• Device Sequence Number: 13757758
• Product Code: QAN
• UDI-Device Identifier: 00801741103445
• UDI-Public: (01)00801741103445
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/28/2021

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: VENUM14100
• Device Catalogue Number: VENUM14100
• Device Lot Number: ANEX1731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/26/2021; 04/28/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/21/2021; 05/17/2021
• 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