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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX PORCINE SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX PORCINE SURGICAL MESH Back to Search Results
Catalog Number 1161020
Device Problems Device Expiration Issue (1216); Use of Device Problem (1670)
Patient Problems Unspecified Infection (1930); Peritonitis (2252)
Event Date 02/24/2017
Event Type  Injury  
Manufacturer Narrative
As reported, the user inadvertently implanted an expired graft that was provided to the user facility prior to the expiration date. Based on this information the root cause for the expired device being implanted is use related. Regarding the patient developing acute peritonitis the root cause is inconclusive. The surgeon who explanted the xenmatrix graft, was asked if the peritonitis was caused/contributed to by the graft that was used, he could not say either way, but he was not convinced that the graft was at fault as it was only days old. Due to the privacy laws of canada patient specific information was not provided. A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned.
 
Event Description
The following was reported to davol. On (b)(6) 2017 - the patient was implanted with a xenmatrix graft. Following surgery it was noted that the implanted graft had an expiry date of 01/31/2017 and had inadvertently been implanted seven days after the labeled expiry. It was reported that the patient had been made aware of this event, but no medical intervention was taken. On (b)(6) 2017 ¿ it was later reported that the patient had developed acute peritonitis and underwent an additional procedure. During this procedure the xenmatrix graft was explanted. The surgeon reports that he could not determine a definitive cause of the peritonitis that presented, however was not convinced that the graft was at fault for the development of the acute peritonitis. There was no connection made between the devices implanted after its labeled expiration period being the cause of the problem that presented.
 
Manufacturer Narrative
This is an addendum to the initial mdr to document additional information obtained through follow up activities with the surgeon. The surgeon indicated that the patient was an elderly woman with a history of complicated surgeries and reports there was no link between the xenmatrix graft and the complications experienced by the patient. Regarding infection the warning section of the ifu states, "if an infection develops it should be treated aggressively. " additionally, the adverse reaction section lists infection as a potential complication. Due to the privacy laws of (b)(6), patient specific information was not provided. A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
This is an addendum to the initial mdr to document additional information obtained through follow up activities with the surgeon. It was initially reported that the patient had developed acute peritonitis and underwent an additional procedure. Additional information provided indicates that the patient experienced a sudden pain and deep surgical site infection resulting in the further surgical intervention. The acute peritonitis had erupted as a result of this infection. The surgeon decided to remove the graft purely as a foreign body at the time of surgery. The surgeon reports that there was no link between the xenmatrix graft and the complications experienced by the patient. The surgeon also indicated that the patient was an elderly woman with a history of complicated surgeries. Patient has not suffered markedly from her surgery post removal of the graft and the patient is currently back to her baseline.
 
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Brand NameXENMATRIX
Type of DevicePORCINE SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6384159
MDR Text Key69254976
Report Number1213643-2017-00156
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K081272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2017
Device Catalogue Number1161020
Device Lot NumberHUYK1415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/07/2017 Patient Sequence Number: 1
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