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

Model Number	VENUM18100
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2022).
Event or Problem Description
It was reported that during a stent placement procedure in the left common iliac vein through the femoral vein, the stent delayed in opening and the catheter was stuck on the stent.It was further reported that the stent was deployed upon rotating the handle multiple times but the struts were slightly misaligned.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 delivery system was returned for evaluation.The condition of the returned delivery system confirmed an expansion issue.The stent brake of the inner catheter which had been under the stent during deployment was found shifted to distal with heavy imprints, and superficial damage which was considered an indication that the stent adhered to the stent brake after deployment leading to breakaway and shifting upon removal, which leads to a confirmed result for expansion issue.Images demonstrating the placed stent were not available so that the alleged strut misalignment could not be confirmed.Based on the information available the investigation is closed with confirmed result.A definite root cause for the reported event could not be determined.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.H10: d4 (expiry date: 10/2022), g3.H11: h6 (results) h11:section a through f - the information provided by bd represents all of 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 procedure in the left common iliac vein through the femoral vein, the stent delayed in opening and the catheter was stuck on the stent.It was further reported that the stent was deployed upon rotating the handle multiple times but the struts were slightly misaligned.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: 11612346
• Report Number: 9681442-2021-00201
• Device Sequence Number: 14234217
• Product Code: QAN
• UDI-Device Identifier: 00801741103728
• UDI-Public: (01)00801741103728
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/21/2021

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: VENUM18100
• Device Catalogue Number: VENUM18100
• Device Lot Number: ANEX6033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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
• Patient Age: 48 YR
• Patient Weight: 80