MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PHASIX ST; SURGICAL MESH

Model Number	1200011
Medical Device Problem Codes	Hole In Material (1293); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Weight Changes (2607)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported postoperative complications and any problem with the bard/davol device used to treat the patient.No definitive conclusion can be made at this time.The patient has not received treatment and is not scheduled for a re-operation as such, the mesh remains implanted.Recurrence is a known inherent risk of hernia repair surgery.Regarding recurrence the warning section of the instructions-for-use states, "to prevent recurrences when repairing hernias, phasix st mesh must be large enough to provide sufficient overlap beyond the margins of the repair/primary closure.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.A review of the manufacturing records was performed and found that the lot was manufactured to specification.It was reported that the patient has gained 25 lbs since the index procedure; there is no information provided indicating that the mesh used to treat the patient caused/contributed to the patient's weight gain.If additional information is provided, a supplemental emdr will be submitted.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.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced a recurrence of the hernia 18 months post implant.On (b)(6) 2016 - the patient underwent laparoscopic implant of the phasix st mesh to repair an umbilical hernia.The mesh was fixated with suture as well as optifix fasteners.The hernia defect measured 2.5cm in length and 2cmin width.As reported the phasix st mesh was positioned so that its edges extended beyond the margins of the defect by at least 5cm.On (b)(6) 2018 - 18 month follow up visit.The patient was diagnosed with a hernia recurrence.The patient was also noted to have gained 25 lbs since the index procedure.The patient is not reporting any pain.Also an area a diastasis has been identified upon physical exam in the area of the repair, which was assessed as not being related to the study device.The hernia recurrence has been assessed as possibly related to the study device and definitely related to the procedure.The patient has not received treatment and is not scheduled for a reoperation at this time.
Event or Problem Description
As reported on (b)(6) 2018.It was reported to davol that a patient who is part of a clinical study experienced a recurrence of the hernia 18 months post implant.(b)(6) 2016 - the patient underwent laparoscopic implant of the phasix st mesh to repair an umbilical hernia.The mesh was fixated with suture as well as optifix fasteners.The hernia defect measured 2.5cm in length and 2cmin width.As reported the phasix st mesh was positioned so that its edges extended beyond the margins of the defect by at least 5cm.(b)(6) 2018 - 18 month follow up visit.The patient was diagnosed with a hernia recurrence.The patient was also noted to have gained 25 lbs since the index procedure.The patient is not reporting any pain.Also an area a diastasis has been identified upon physical exam in the area of the repair, which was assessed as not being related to the study device.The hernia recurrence has been assessed as possibly related to the study device and definitely related to the procedure.The patient has not received treatment and is not scheduled for a reoperation at this time.Addendum: (b)(6) 2018 - the patient underwent a revision procedure.Per operative note, the omentum was separated from the hernia defect that was right through the middle of the old mesh repair (phasix st).The omentum was cleared, the defect was closed with suture and a ventralight st w/ echo ps was placed over the defect to complete the revision procedure.The hernia recurrence was reassessed as definitely related to the device.
Additional Manufacturer Narrative
This is an addendum to the initial emdr to document additional information provided.At this time it is unclear what may have caused or contributed to the recurrence occurring right through the middle of the phasix st mesh repair.The patient is an obese male who is reported to have gained 25lbs since the implant procedure when he was diagnosed with the recurrence.Additionally, the patient was diagnosed with the hernia recurrence at his 18 month follow up visit, per the instructions-for-use, absorption of the mesh material will be essentially complete within 12 to 18 months.It is unknown how these two facts may have contributed to the hernia recurrence.The initial determination remains the same, no definitive conclusion can be made at this time.If additional information is provided, a supplemental emdr will be submitted.

• Brand Name: PHASIX ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7299096
• Report Number: 1213643-2018-00392
• Device Sequence Number: 16416677
• Product Code: OWT
• UDI-Device Identifier: 00801741095283
• UDI-Public: (01)00801741095283
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 1200011
• Device Catalogue Number: 1200011
• Device Lot Number: HUAQ2431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 136