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

Model Number	VENUL14100
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
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 not been returned to the manufacturer for evaluation.However, image was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2022).Device not returned.
Event or Problem Description
It was reported that during a stent placement through right common femoral vein, the device allegedly failed to expand and stent fractured.It was further reported that perforation of vessels occurred.The patient's current status was unknown.
Event or Problem Description
It was reported that during a stent placement through right common femoral vein, the device allegedly failed to expand and stent fractured.It was further reported that perforation of vessels occurred.The patient's current status was unknown.
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.X-ray image provided demonstrating strut irregularity and guidewire being unnaturally close to the stent surface at the stent end were considered an indication that the stent adhered to the inner catheter stent break which leads to a confirmed investigation result for expansion issue.A definitive root cause could not be determined based upon the available information.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.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.

• 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: 11684326
• Report Number: 9681442-2021-00243
• Device Sequence Number: 14233427
• Product Code: QAN
• UDI-Device Identifier: 00801741103513
• UDI-Public: (01)00801741103513
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VENUL14100
• Device Catalogue Number: VENUL14100
• Device Lot Number: ANEP4061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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: Required Intervention