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

Catalog Number J-PF-POST

Device Problem Extrusion (2934)

Patient Problem Abnormal Vaginal Discharge (2123)

Event Type  Injury  

Manufacturer Narrative

This mdr is related to mdr 1835959-2015-00266.Although the patient reportedly experienced some degree of extrusion of the device, the surgisis posterior pelvic floor graft performed as intended in repairing the patient¿s rectocele.As the prolapse was successfully repaired, it is not believed that the patient had a graft versus host reaction.Rather, as the graft began to incorporate, pieces of the graft that may not have been in good contact with viable healthy tissue were possibly expelled.The root cause of the patient¿s current complaints is inconclusive.However, her diagnosis of interstitial cystitis and atrophic vaginitis likely contribute to her symptoms.All other matters relating to this litigation are being handled by our attorney.A follow-up mdr will be filed if additional details are obtained.

Event Description

The patient was reportedly implanted with a surgisis anterior pelvic floor graft and a surgisis posterior pelvic floor graft, on (b)(6) 2007, for anterior and posterior vaginal repairs with bilateral sacrospinous ligament fixation.The surgery was performed by dr.(b)(6) and took place at (b)(6) hospital in (b)(6).The patient reportedly experienced vaginal discharge with the appearance of strings and thick cotton like pieces beginning one week after surgery and lasting for approximately one year.During that time, the patient had these extrusions trimmed on a few occasions.Dr.(b)(6) examination note on (b)(6) 2007 indicated the patient might be experiencing graft versus host reaction.The patient reported that the rectocele and cystocele were successfully repaired.

• Brand Name: BIODESIGN POSTERIOR PELVIC FLOOR GRAFT
• Type of Device: PELVIC FLOOR POSTERIOR
• 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: 5299774
• MDR Text Key: 33596272
• Report Number: 1835959-2015-00267
• Device Sequence Number: 1
• Product Code: PAI
• 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: Attorney
• Type of Report: Initial
• Report Date: 12/15/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: J-PF-POST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 54