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

Model Number	VP-706-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post operatively, on a minimally invasive surgery through the right thoracic line, patching the ventricular septal defect with a mesh, after sudden bleeding of more than 500cc, the patient's blood pressure was 10-20 mmhg, cardiac arrest, was treated with cardiopulmonary resuscitation, fluid resuscitation and vasopressor with a diagnosis of fulminant blood loss.The surgical team cooperated with resuscitation, and anesthesia and midline thoracotomy.The user found out the break in the middle of the five atrial sutures including two layers and the two ends of the thread were still intact.The operator conducted a pair of atrial clamps, sutured the atrial suture with squeezing the thread with two layers.It was noted that compensation for blood, fluid, coordinated with active resuscitation, the patient had a rhythm again, occurred ventricular fibrillation, electric shock of 10 joules, sinus rhythm.Resuscitation was effective, hemodynamic stability and the surgeon closed the chest midline for the patient.The patient was hospitalized.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the suture thread broke.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The evaluation detected an unreported condition: the suture was noted to have kinks.The most likely cause for the additional condition is linked to device but unable to trace more specifically.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, while the patient was in the intensive care unit (icu) for two hours, on a minimally invasive surgery through the right thoracic line, patching the ventricular septal defect with a mesh, after sudden bleeding of more than 500cc, the patient's blood pressure was 10-20 mmhg, cardiac arrest, was treated with cardiopulmonary resuscitation, fluid resuscitation and vasopressor with a diagnosis of fulminant blood loss.The surgical team cooperated with resuscitation, and anesthesia and midline thoracotomy.The user found out the break in the middle of the 5 atrial sutures including 2 layers and the 2 ends of the thread were still intact.The operator conducted a pair of atrial clamps, sutured the atrial suture with squeezing the thread with 2 layers.It was noted compensation for blood, fluid, coordinated with active resuscitation, the patient had a rhythm again, occurred ventricular fibrillation, electric shock of 10 joules, sinus rhythm.Resuscitation was effective, hemodynamic stability and the surgeon closed the chest midline for the patient.The patient was hospitalized.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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, CO 55112 ; 7635265677
• MDR Report Key: 14845737
• Report Number: 9612501-2022-01069
• Device Sequence Number: 2350706
• Product Code: GAW
• UDI-Device Identifier: 10884521038264
• UDI-Public: 10884521038264
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2022

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 Expiration Date: 11/30/2025
• Device Model Number: VP-706-X
• Device Catalogue Number: VP-706-X
• Device Lot Number: D0M0416Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 08/29/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/02/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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: VP-706-X SURIGPRO (LOT NUMBER: D0M0416Y).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 9 YR
• Patient Sex: Male