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Catalog Number 0116001
Event Date 03/03/2010
Event Type  Death  
Event Description

The following is reported by the patient's attorney: (in summary) on (b)(6) 2008 - ot underwent laparoscopic repair of paraesophageal hernia with bard crurasoft patch. Repair consisted of patch closure of the esophageal hiatus, gastroplexy and partial fundoplication. On (b)(6) 2008 - patient was seen for heartburn and "almost regurgitation. " "tight wrap" was suggested. Pt was also experiencing bile reflux and suffering from marked dysphasia. On (b)(6) 2008 - pt's weight dropped to (b)(6), from pre-surgery of (b)(6). Unable to tolerate solid foods and liquids. Md, during his evaluation of the pt, described her as "extremely cachectic". On (b)(6) 2009 - pt's weight had dropped to (b)(6). Pt was admitted to the hospital with a diagnosis of failure to thrive. On (b)(6) 2009 - pt underwent exploratory laparotomy, lysis of adhesions, removal of infected mesh, esophagogastrectomy with primary anastomosis, and feeding tube placement. Post-op diagnosis, infected diaphragmatic mesh, recurrent paraesophageal hernia, and slipped partial fundoplication. Stomach was freed from diaphragm, white material found, which evidently had food particles in it; direct communication with mesh. Significant stricture right at the ge junction and did not appear to be related to a too tight wrap but appeared to be intrinsic to esophagus and may have been related to inflammation related to infected mesh. Due to extensiveness of inflammation at ge junction, an extended esophagoplasty was performed. On (b)(6) 2010 - pt underwent surgery for stage iv sacral decubitus. The surgeon found a large grossly infected cavity. On (b)(6) 2010 - the pt' s health continued to decline, and she expired. Attorney alleges pt suffered serious bodily injuries ultimately leading to her death.

Manufacturer Narrative

We have contacted the initial report to request additional information and to request return of the device for evaluation. This mdr includes all patient, event and device information davol has received to date. Based on the information provided, it is unknown whether the device may have caused or contributed to the reported event. The attorney alleges the patient experienced several complications following the implant of the crurasoft patch and subsequently resulting in the patient's death. Currently, medical records, autopsy report, and/or a death certificate have not been provided although requested several times. The information provided indicates that the patient developed and was treated for an infection. The warning section of the ifu states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. " a review of the manufacturing records was performed including a review of sterility records and there was no evidence of a manufacturing related cause for the reported event. Additionally, no sample was returned for evaluation. A supplemental report will be submitted if/when additional information is provided. With the currently available information, no conclusion can be drawn.

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Manufacturer (Section D)
warwick RI
Manufacturer (Section G)
san geronimo industrial park
lot #1, rd #3, km 79.7
humacao PR 00791
Manufacturer Contact
corie vazquez
100 crossings blvd.
warwick , RI 02886
MDR Report Key2537636
Report Number1213643-2012-00249
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/21/2012
Device Catalogue Number0116001
Device LOT NumberHURI1035
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Hospital
Date Manufacturer Received03/08/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 04/05/2012 Patient Sequence Number: 1