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

Model Number	1161928
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made as to the degree to which the xenmatrix graft may have caused or contributed to the patient's condition.At this time, it is unclear what caused the patient to experience tachycardia post implant.Additional information has been requested.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june, 2017.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The date of implant is an estimate based on the reported date of event.Should additional information be obtained, 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 is reported that the patient developed a recurrence incisional hernia and underwent an extensive laparotomy during which adhesiolysis had to be performed.The patient was taken back into theatre two days following this procedure to have a davol xenmatrix graft placed.It is reported that two days post implant of the graft the patient started experiencing tachycardia (a rapid resting heartbeat).As reported the anesthetist has ruled out other possible events that may cause tachycardia and is now inquiring about the mesh as this is the only other variable.It is reported that when the product was placed, there were no physical defects.It was well within expiry date and had been stored in a cooling fridge.As reported the patient has a medical / surgical history significant for multiple recurrent hernias and repair.As reported over the last 10 years the patient has had 4 x synthetic meshes placed, and just over a year ago had 1 x biologic mesh placed (non-davol product).
Additional Manufacturer Narrative
This is addendum to the initial emdr to document additional and corrected information provided by the contact.Based on the reported histological findings it does not appear that the patient's tachycardia is associated to the xenmatrix graft, however a definitive root cause has not been identified.The results of this investigation remain inconclusive.Should additional information be obtained, a supplemental emdr will be submitted.
Event or Problem Description
As previously reported on (b)(6) 2018: it is reported that the patient developed a recurrence incisional hernia and underwent an extensive laparotomy during which adhesiolysis had to be performed.The patient was taken back into theatre two days following this procedure to have a davol xenmatrix graft placed.It is reported that two days post implant of the graft the patient started experiencing tachycardia (a rapid resting heartbeat).As reported the anesthetist has ruled out other possible events that may cause tachycardia and is now inquiring about the mesh as this is the only other variable.It is reported that when the product was placed, there were no physical defects.It was well within expiry date and had been stored in a cooling fridge.As reported the patient has a medical/surgical history significant for multiple recurrent hernias and repair.As reported over the last 10 years the patient has had 4 x synthetic meshes placed, and just over a year ago had 1 x biologic mesh placed (non-davol product).Addendum: (follow up 1) the patient underwent an additional procedure to remove the xenmatrix graft.As reported the explanted graft was sent for histology.In follow up with the doctor and the anaesthetists and it was stated that there were no histological findings that could prove that the mesh was the cause of the patient¿s physiological response.

• Brand Name: XENMATRIX
• Common Device Name: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7310321
• Report Number: 1213643-2018-00449
• Device Sequence Number: 956937
• Product Code: FTM
• UDI-Device Identifier: 00801741031434
• UDI-Public: (01)00801741031434
• Combination Product (Y/N): N
• PMA/510(K) Number: K081272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: 05/28/2019
• Device Model Number: 1161928
• Device Catalogue Number: 1161928
• Device Lot Number: HUBS2327
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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 Weight: 90