MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442 VENOVO VENOUS STENT

Catalog Number	VENUM18140
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient prepped for a stent placement procedure using the venovo venous stent.It was reported that prior to the procedure; the delivery system was allegedly damaged.There was no patient contact.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were 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 is not available for evaluation.Provided image demonstrates four green card boxes inside a brown card box.The four product card boxes are damaged but the brown card box appears not damaged on the visible section of the image.It is not known whether this brown card box was the shipping box.The investigation leads to confirmed result for packaging damage.A manufacturing related issue could not be found.Based on the investigation of the provided information, the investigation is closed as confirmed for packaging damage.A definite root cause for the reported event could not be determined.Labelling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use (ifu) state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.G3, h6 (method, result, conclusion).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
A patient prepped for a stent placement procedure using the venovo venous stent.It was reported that prior to the procedure, the delivery system was allegedly damaged.There was no patient contact.

• Brand Name: VENOVO VENOUS STENT
• Common Device Name: VENOUS STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22780628
• Report Number: 9681442-2025-00240
• Device Sequence Number: 18186729
• Product Code: QAN
• UDI-Device Identifier: 00801741103742
• UDI-Public: (01)00801741103742(17)270121(10)ANKN2219
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P180037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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 Catalogue Number: VENUM18140
• Device Lot Number: ANKN2219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown