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

Model Number	VP703X-2
Medical Device Problem Codes	Unraveled Material (1664); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Cardiac Arrest (1762); Hematoma (1884)
Date of Event	01/22/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively of a coronary artery bypass surgery, an anastomotic suture on a bypass graft fractured and disrupted in its mid-portion, engendering a life-threatening emergency for the patient.It was also stated that prosthetic vascular tube implants never healed but rather delay for decades on the integrity of the anastomotic suture material.The patient died.
Event or Problem Description
According to the reporter, two days post-operatively of a coronary artery bypass surgery x3 using cardiopulmonary bypass: left internal mammary artery (lima) to left anterior descending artery (lad); saphenous vein graft to d1; and saphenous vein graft to om1, an anastomotic suture on a bypass graft fractured and disrupted in its mid-portion, engendering a life-threatening emergency for the patient.Patient sustained cardiac arrest, mediastinal hematoma, and chest opened at bedside in intensive care unit (icu).The patient was returned to the operating room for emergent reoperative coronary artery bypass x1 using cardiopulmonary bypass: left internal mammary artery to lad, revision of central extracorporeal membrane oxygenator (ecmo device to peripheral va-ecmo (right axillary artery), and percutaneous insertion of intra-aortic balloon pump.It was also stated that prosthetic vascular tube implants never heal but rather delay for decades on the integrity of the anastomotic suture material.The patient died.
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 II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• MDR Report Key: 11420749
• Report Number: 9612501-2021-00353
• Device Sequence Number: 4461408
• Product Code: GAW
• UDI-Device Identifier: 10884521758223
• UDI-Public: 10884521758223
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K010909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: VP703X-2
• Device Catalogue Number: VP703X-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening