MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN

Model Number	VP-521-X
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: vp-521-x, vp-521-x surgipro ii 4-0 blu 90cm v20da (lot#:d2h2342gy) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter during a procedure, two sutures experienced issues.It was noted that one suture broke in the middle while suturing, and the other failed to hold the suture line during the procedure.As a result, the surgical time was extended to allow for re-anastomosis and the healthcare team resolved the issue by switching to sutures from another manufacturer.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a heart valve replacement, two sutures experienced issues.It was noted that one suture broke in the middle while suturing, and the other failed to hold the suture line during the procedure.As a result, the surgical time was extended for 20 minutes to allow for re-anastomosis, and the healthcare team resolved the issue by switching to sutures from another manufacturer.

• Brand Name: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22509595
• Report Number: 9612501-2025-01858
• Device Sequence Number: 9247130
• Product Code: GAW
• UDI-Device Identifier: 10884521037786
• UDI-Public: (01)10884521037786(17)280930(10)D3K3513GY(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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 Model Number: VP-521-X
• Device Catalogue Number: VP-521-X
• Device Lot Number: D3K3513GY
• 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: 06/22/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/01/2025
• Date Device Manufactured: 10/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown