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

Model Number	VENUM16080
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record 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: 09/2022).
Event or Problem Description
It was reported that during a stent placement through common ilac vessel, the device allegedly failed to expand in the distal end.There was no reported injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review could not be performed as the lot number is unknown investigation summary: the returned sample was found with shifted stent brake, but the introducer was found stuck over the system so that the distal end was located over the stent brake.It was not known what exactly caused the stent brake to shift in distal direction and why the introducer was removed together with the system.Images were not provided.In addition, the surface of the stent brake was found in good condition so that an expansion issue could not be confirmed leading to inconclusive evaluation result.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 instruction for use for this product was conducted.The instruction 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.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 a stent placement through common iliac vessel, the device allegedly failed to expand in the distal end.There was no reported 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: 11000958
• Report Number: 9681442-2020-20076
• Device Sequence Number: 16301123
• Product Code: QAN
• UDI-Device Identifier: 00801741103575
• UDI-Public: (01)00801741103575
• 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,Followup
• Report Date (Section B): 05/17/2021

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: VENUM16080
• Device Catalogue Number: VENUM16120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 06/21/2021
• 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