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

Model Number	VENUL14160
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
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 and photo were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022).
Event or Problem Description
It was reported that during a stent placement procedure via access through the bilateral saphenous vein, the device allegedly difficult to deploy.It was further reported that the stent was found to be twisted.The procedure was completed using the same device.There was no reported patient injury.
Additional Manufacturer Narrative
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 silicone brake of the inner catheter which is under the stent was found shifted to distal with superficial damage which indicated that the stent adhered to the brake leading to breakaway and shifting upon removal.The silicone brake was found over the tip which confirmed the statement that the stent got stuck at the tip.Stent strut kink was confirmed on one image, twist could not be identified on the provided images.The condition of the returned catheter sample, and images provided 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.D4(expiry date: 08/2022).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.
Event or Problem Description
It was reported that during a bilateral stent placement procedure in the iliac vein through bilateral saphenous vein access, the device allegedly did not release from the system because it remained attached to the blue stent brake.The user rotated the system for complete expansion; upon removal the system got stuck on the tip which led to stent kink at the distal end.Balloon dilation was performed to fully open the stent but the stent end remained bent.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: 11085793
• Report Number: 9681442-2020-20120
• Device Sequence Number: 19515845
• Product Code: QAN
• UDI-Device Identifier: 00801741103544
• UDI-Public: (01)00801741103544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/22/2021

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: VENUL14160
• Device Catalogue Number: VENUL14160
• Device Lot Number: ANEV4030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 03/11/2021
• 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