MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN POSTERIOR PELVIC FLOOR GRAFT

Catalog Number J-PF-POST

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Seroma (2069); Complaint, Ill-Defined (2331); Malaise (2359); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Lot number lb56967c, as noted by the complainant, is not a valid cbi lot number.The reported lot number was unable to be narrowed down to a valid cbi lot number.This mdr is related to mdr 1835959-2016-00626.The lot number lb56967c, as noted by the complainant, is not a valid cbi lot number.The reported lot number was unable to be narrowed down to a valid cbi lot number.A review of the cbi complaint database did not reveal any previously reported complaints that match the details of this feedback.The ifu notes that "the following complications are possible with the use of surgical graft materials: bleeding, infection, adhesions, sterile effusion, chronic inflammation, allergic reaction, and delayed or failed incorporation of graft.If conditions of infection, inflammation, or allergic reaction cannot be resolved, consider removal of the graft." based on the information provided by the complainant, details regarding a specific correlation between the biodesign surgisis posterior pelvic floor graft's performance and the alleged injury remain unknown.A root cause of the allegations is inconclusive due to the lack of details provided by the complainant.

Event Description

The patient filed a device incident report to the (b)(6).This was documented as device incident report (b)(6).The patient reported she was implanted with two surgisis biodesign posterior pelvic floor grafts.One graft was placed in the anterior vaginal compartment and the other graft was placed in the posterior vaginal compartment.The date of implantation, surgical procedure performed, facility in which the surgery took place and the surgeon's name were not provided by the complainant.The patient reported experiencing continuous post-operative pain and a general feeling of being unwell.She also reported a discharge of blood and an offensive smell.The pain was described as sharp and stringing throughout the pelvic region.The patient also reported having persistent infections followed by skin changes, a loss of balance, and general malaise with the pain throughout the first twelve months after surgery.She indicated that the pain still persists, at the present time, and that the systems for which the procedure was performed to correct are worse than before surgery.The patient reports having permanent incontinence of both bowel and bladder and a foul smelling pelvic discharge (putrid seroma).She indicated she has had a loss of quality of life and is unable to have sexual intercourse.The patient reports that the products are unable to be removed and have caused irreparable internal damage.

Manufacturer Narrative

Date of event not provided by the complainant.Product common posterior pelvic floor graft; product code pag.Lot number lb56967c, as noted by the complainant, is not a valid cbi lot number.The reported lot number was unable to be narrowed down to a valid cbi lot number.Product expire date unknown; lot number not provided.Implant date reported as (b)(6) 2012.Product manufacture date unknown; lot number unknown.This mdr is related to mdr 1835959-2016-00626.The lot number lb56967c, as noted by the complainant, is not a valid cbi lot number.The reported lot number was unable to be narrowed down to a valid cbi lot number.A review of the cbi complaint database did not reveal any previously reported complaints that match the details of this feedback.The ifu notes that "the following complications are possible with the use of surgical graft materials: bleeding, infection, adhesions, sterile effusion, chronic inflammation, allergic reaction, and delayed or failed incorporation of graft.If conditions of infection, inflammation, or allergic reaction cannot be resolved, consider removal of the graft." based on the information provided by the complainant, details regarding a specific correlation between the biodesign surgisis posterior pelvic floor graft's performance and the alleged injury remain unknown.A root cause of the allegations is inconclusive due to the lack of details provided by the complainant.Update: the additional details received do not alter the previous investigation summary.

Event Description

Per device incident report (b)(4).Two x grafts were implanted in both anterior ((b)(4)) & posterior ((b)(4)) compartments of vagina.Pain in the vaginal region was continuous, general feeling unwell persisted continually after surgery.Having pain and continuously, discharge of blood tissue and offensive smell.Sharp, stringing pain throughout pelvic region.Persistent infections followed by skin changes and loss of balance, general malaise continuing with pain intensity throughout first 12 months continually - till present time.All of the systems which the operation was performed to correct are now worse than ever.Permanent incontinence from both bowel & urethra.Persistent pain associated with new formation of number of adhesions, product has integrated, with natural tissue causing all pelvic tissue to become necrotic causing continuous pelvis discharge with foul smell (putrid seroma).Loss of quality of life, unable to have sexual intercourse.Product is unable to be removed and has caused irreparable damage internally.Update: new information received which revealed the patient's identity, age at the time of biodesign surgisis posterior pelvic floor graft(s) implant, surgeon's name, geographical location implant took place, and date of implant.In (b)(6) 2012, the patient underwent surgery performed by dr.(b)(6) in (b)(6), for repair of minor incontinence and pelvic prolapse issues.

• Brand Name: BIODESIGN POSTERIOR PELVIC FLOOR GRAFT
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 6053408
• MDR Text Key: 58300324
• Report Number: 1835959-2016-00627
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K992159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-PF-POST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: J-PF-POST
• Patient Outcome(s): Disability
• Patient Age: 48 YR