MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD SAUVAGE FILAMENTOUS FABRIC; SAUVAGE FABRIC

Catalog Number	007829
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.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.
Event or Problem Description
A patient underwent a surgical graft placement procedure on the carotid artery procedure using bard sauvage filamentous fabric.During the procedure, the patch allegedly found with leaked.It was further reported that the patch remained porous despite blood soakinhematoma and further use of hemostatics, leaded to persistent bleeding.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: three electronic photos were reviewed.Two images show what appears to be a hematoma with gauze placed over.The gauze is bloody over the hematoma.The reported bleeding and hematoma can be confirmed.The third image shows what appears to be the sauvage patch implanted in the patient.Blood can be seen externally on the patch.However, it cannot be determined if the blood is leaking through the patch or if the blood is from a separate source based on the image alone.Therefore, the investigation remains inconclusive for the reported leak through the ptfe patch.It is possible the patch is leaking in the provided photo, but it is not able to be confirmed based on the image alone that the source of the blood on the external side of the patch is due to a leak.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (component, 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 underwent a surgical graft placement procedure on the carotid artery procedure using bard sauvage filamentous fabric.During the procedure, the patch allegedly found leaking.It was further reported that the patch remained porous despite blood soaking and further use of hemostatics, leaded to persistent bleeding and a large neck hematoma.The current status of the patient is unknown.

• Brand Name: BARD SAUVAGE FILAMENTOUS FABRIC
• Common Device Name: SAUVAGE FABRIC
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23475890
• Report Number: 2020394-2025-01843
• Device Sequence Number: 10558379
• Product Code: DXZ
• UDI-Device Identifier: 00801741041051
• UDI-Public: (01)00801741041051(17)290328(10)HUJR0750
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K770835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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 Catalogue Number: 007829
• Device Lot Number: HUJR0750
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 02/24/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown