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

Catalog Number J-PF-POST

Device Problems Break (1069); Material Erosion (1214); Material Protrusion/Extrusion (2979)

Patient Problems Incontinence (1928); Pain (1994); Urinary Frequency (2275); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with a boston scientific pinnacle anterior pelvic floor repair kit, a bard align to urethral support system, and a surgisis posterior pelvic floor graft on (b)(6) 2011 at (b)(6), by dr.(b)(6).Dr.(b)(6) performed a sacrospinous ligament fixation with mesh reinforcement, anterior colporrhaphy with mesh reinforcement, posterior colpoperineorrhaphy with graft reinforcement, enterocele repair, and a cystoscopy for the treatment of the patient's stage iv complete post-hysterectomy vaginal vault prolapse with associated cystocele, rectocele, and enterocele, and mixed urinary incontinence.During the procedure, the pinnacle mesh was felt to not have appropriately supported the apex, so this mesh product was removed, and a new pinnacle mesh product was retailored and implanted.Also during the procedure, while tensioning the align sling, the sling broke and had to be removed.The align sling, the sling broke and had to be removed.The align sling was then replaced in the mid-urethra in a tension-free fashion, and excess sling was trimmed.Since the (b)(6) 2011 surgery, the patient has had the mesh trimmed and has experienced urinary urgency, frequency, incontinence, and nocturia, fells a sensation of protrusion, problems with bowel movements, and erosion of some of the mesh.The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury and has undergone medical treatment.The following information was not provided by the complainant: specific information of the alleged injury, specific information regarding whether intervention was performed, specific information regarding why intervention was performed or what type/to what extent intervention was performed, specific correlation between device performance nad alleged injury, current patient status.

Manufacturer Narrative

Date of event not provided by the complainant.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product manufacture date unknown; lot number unknown.Conclusion: root cause inconclusive due to lack of details provided by the complainant.Investigation into this claim included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our attorney.Based on the information provided by the complainant, details regarding a specific correlation between the unspecified surgisis product's performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.If/when additional information is obtained, a follow-up mdr will be filed.

• Brand Name: BIODESIGN POSTERIOR PELVIC FLOOR GRAFT
• Type of Device: POSTERIOR PELVIC FLOOR GRAFT
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906
• Manufacturer Contact: perry quinn, vp qa/ra ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 4092153
• MDR Text Key: 4831104
• Report Number: 1835959-2014-00914
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• 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: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFC PINNACLE ANTEIOR PELVIC FLOOR,; REPAIR KIT M068317050, LOT 831-705; BARD ALIGN TO URETHRAL SUPPORT SYSTEM BRD500HL,; LOT HUVD0869