MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-GUARD; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Sepsis (2067); Thrombosis/Thrombus (4440)

Event Type  Death  

Manufacturer Narrative

Gender: 13 men and 7 women.Event date: (b)(6) 2015 and (b)(6) 2017.Initial reporter facility name: (b)(6).Literature article: kreibich, m., siepe, m., morlock, j., beyersdorf, f., kondov, s., scheumann, j., kari, f.A., md, berger, t., schr¿ofel, h., rylski, b.And czerny, m.¿surgical treatment of native and prosthetic aortic infection with xenopericardial tube grafts¿.Ann thorac surg (2018) aug;106 (2):498¿504.Doi: 10.1016/j.Athoracsur.2018.03.012.Epub 2018 apr 11.The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported 20 patients underwent a study in which peri-guard was used with surgical treatment of native and prosthetic aortic infection with xenopericardial tube grafts.It was reported one patient developed thrombotic occlusion and was treated with a conventional crossover bypass.One patient developed neoaortointestinal fistulation and was treated with removal of the xenopericardial tube graft without restoration of continuity.Two patients experienced sepsis.Treatment for the sepsis was not reported.It was reported two patients passed away postoperatively.The cause of death was reported as due to ongoing sepsis.It was not reported if an autopsy was performed.No additional information is available.

• Brand Name: PERI-GUARD
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 11837526
• MDR Text Key: 251091482
• Report Number: 1416980-2021-02980
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention