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

Model Number	VP-842-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: unknown - sutur, unknown suture product (lot#unknown); unknown - sutur, unknown suture product (lot#unknown).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
It was reported that during the use of sutures to anastomose an aortic graft, the tip of the needle broke away from the needle while suturing.The needle tip could not be retrieved from the patient, and the surgeon deemed it unsafe to attempt locating the tip.The area being sutured was heavily calcified, and the needle tip had been picked up by the needle holder.Additionally, two further needles used in the same case detached at the swage.It was noted that the patient died due to a cardiac arrest.
Additional Manufacturer Narrative
Additional information: d4 (udi #), g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the needle was observed to be attached to a partial suture.The tip of the needle was observed to be damaged and the needle point was noted to be missing.It was reported that the tip of the needle broke.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.

• Brand Name: SURGIPRO LL
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22114489
• Report Number: 9612501-2025-01398
• Device Sequence Number: 4251534
• Product Code: GAW
• UDI-Device Identifier: 10884521039377
• UDI-Public: (01)10884521039377(17)280531(10)D3F1366Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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 Model Number: VP-842-X
• Device Catalogue Number: VP-842-X
• Device Lot Number: D3F1366Y
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown