XENMATRIX AB 1151935

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2018-01-30 for XENMATRIX AB 1151935 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

Event Text Entries

[98628945] There is no connection that can be made at this time between the reported post-operative complications (infected seroma) and any problem with the bard/davol xenmatrix ab graft used to treat the patient. As reported the graft was implanted into a contaminated environment and the patient was later diagnosed with an infected seroma. The adverse event of infected seroma was classified by the clinician as being possible related to the study device and possibly related to the procedure. No definitive conclusion can be made at this time. The patient's treatment continues at this time, and the graft remains implanted. Regarding infection the warning section of the instructions-for-use states, "this device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. Additionally, seroma formation is a known inherent risk of surgery and is identified in the adverse reaction section of the instructions-for-use as a potential complication. Should additional information is provided, a supplemental emdr will be submitted. This emdr documents information associated to the bard/davol xenmatrix ab graft, an additional emdr was submitted to document information associated to the bard/davol kugel mesh. 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. Remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[98628946] It was reported to davol that a patient who is part of a clinical study experienced a post operative infected seroma. On (b)(6) 2002 - the patient was implanted with a bard/davol kugel mesh for the repair of a recurrent midline hernia. On (b)(6) 2017 - the patient underwent the implant of a xenmatrix ab graft and colon resection, during this procedure a previously placed "kugel" mesh was explanted. The hernia site wound classification is listed as being a class iv (dirty-infected). The patient is noted to have a bacterial infection with (b)(6), escherichia coli, enterococcus avium, and bacteroides fragilis. An intraperitoneal with component separation technique was used. The procedure was performed in open fashion and a fistula is noted to have been present at the time of surgery. The size of the hernia defect was 30cm in length and 13cm in width. The xenmatrix ab graft was trimmed and a 5cm overlap was maintained around the hernia defect. The hernia was located in the midline abdomen and involved the subxiphoid, epigastric, umbilical, infraumbilical and suprapubic areas. The mesh was sutured with long-term absorbable monofilament sutures using 31 fixation points. The midline fascia and skin were completely closed. Drains were inserted into the left upper quadrant, left lower quadrant, and the right lower quadrant. On (b)(6) 2017 - the patient was diagnosed with acute blood loss anemia. This adverse event was assessed as not related to the device (xenmatrix ab) and possibly procedure related. The patient received 2 units of packed red blood cells. On (b)(6) 2017 the patient was diagnosed with dehydration. This adverse event was assessed as not related to the device (xenmatrix ab) and not related to the procedure. The patient received iv fluids and monitoring. On (b)(6) 2017 - the patient was admitted to the hospital with abdominal pain and was diagnosed with a surgical site infection (ssi), iv and oral antibiotics were administered and a drain was placed. The ssi is noted to be in the deep tissue layer with purulent drainage. An infected seroma is noted to have been present. The bacterial growth cultured to be streptococcus anginosus. An abdominal ct scan was performed, a drain was placed, and the patent received 1 unit of packed red blood cells. Treatment continues. The adverse event of infected seroma was classified by the clinician as being possible related to the study device and possibly related to the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213643-2018-00160
MDR Report Key7229085
Report SourceHEALTH PROFESSIONAL,OTHER,STU
Date Received2018-01-30
Date of Report2018-01-30
Date of Event2017-12-23
Date Mfgr Received2018-01-05
Device Manufacturer Date2015-12-15
Date Added to Maude2018-01-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAURA SUNDBERG
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone4018258462
Manufacturer G1BARD SHANNON LIMITED -3005636544
Manufacturer StreetSAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7
Manufacturer CityHUMACAO PR 00791
Manufacturer CountryUS
Manufacturer Postal Code00791
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameXENMATRIX AB
Generic NamePORCINE SURGICAL MESH
Product CodePIJ
Date Received2018-01-30
Model NumberNA
Catalog Number1151935
Lot NumberHUZJ0043
Device Expiration Date2017-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Manufacturer Address100 CROSSINGS BLVD. WARWICK RI 02886 US 02886


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-01-30

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