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

Model Number	VENUL14040
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
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.However, an image was provided for review.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 procedure, the stent was allegedly failed to expand.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure, the stent allegedly failed to expand.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 sample was returned for evaluation.The condition of the returned catheter sample, and image provided confirmed the alleged expansion issue.The silicone brake of the inner catheter which is under the stent was found shifted to distal which indicated that the stent adhered to the brake leading to breakaway, and shifting upon removal.The hour glass like deformation on the stent in the area of the silicone cushion also confirmed the alleged expansion issue.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant labeling 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.The reported placement in renal vein represents an off label use of the device.Based on the instructions for use supplied with this product the venovo venous stent system is indicated for treatment of symptomatic iliofemoral venous outflow obstruction.H10: d4 (expiry date: 09/2022), g4.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 : see h10.

• Brand Name: VENOVO VENOUS STENT SYSTEM
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11044438
• Report Number: 9681442-2020-20104
• Device Sequence Number: 1087155
• Product Code: QAN
• UDI-Device Identifier: 00801741103483
• UDI-Public: (01)00801741103483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/07/2021

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: VENUL14040
• Device Catalogue Number: VENUL14040
• Device Lot Number: ANEW2530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 03/01/2021
• 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
• Patient Age: 30 YR