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

Catalog Number J-PF-ANT-USL

Device Problem Extrusion (2934)

Patient Problems Pain (1994); Injury (2348)

Event Date 03/14/2012

Event Type  Injury  

Manufacturer Narrative

Method: actual device not evaluated; no testing methods performed as device was not returned to the mfr.Results: no results available since no eval performed.Conclusion: root cause likely related to another mfr's product.Investigation - eval: investigation into this report included 1) a review of the claim allegations, 2) a review of the cbi complaint system, 3) a review of the device history records which indicated the products were mfg to specs, 4) a review of the biodesign surgisis anterior pelvic floor graft ifu fp0040-01d, and 5) all other communication and investigation into this report/claim is being handled by our attorney.Summary of investigation findings: after reviewing the details rec'd, it does not appear that the biodesign surgisis anterior pelvic floor graft caused or contributed to any life threatening illness or injury, permanent impairment or damage, nor did the pt require medical or surgical intervention to preclude serious injury or death as a result of the graft being placed.The pt did not experience any symptoms as a result of the biodesign surgisis anterior pelvic floor graft being placed that should they recur would be likely to cause or contribute to death, serious injury, or require medical or surgical intervention to preclude serious injury or death.The root cause of the pt's vaginal polyps, vaginal pain, vaginal discharge, and vaginal bleeding may likely be related to some type of inflammatory reaction to the ethibond permanent suture which was used in the (b)(6) 2011 surgery.The eroded mesh noted in the (b)(6) 2012 appears to have been an extrusion of mesh from the area of excised ethibond suture material and not truly erosion of the biodesign surgisis graft/sling.This graft/sling material was likely unable to incorporate into the host tissue adequately due to the pt's response to the ethibond suture material.With the info provided, whether or not the pt had recurrence of her stress urinary incontinence is unclear.There was no indication of recurrence of the cystocele or rectocele.All other matters relating to this litigation are being handled by our attorney.If/when add'l info is obtained a follow-up mdr will be filed.This mdr is related to mdr 1835959-2013-00010.

Event Description

On (b)(6) 2011, the pt was reportedly implanted with a) biodesign j-pf-ant-usl, b) j-stfk-8-2x40, c) surgisis 4 layer, tissue j-slh-4s-7x10 and d) american medical screw bone ultra kit; catalog # 72403886, lot # 659612.The surgery took place at (b)(6) hosp in (b)(6) and was performed to correct the pt's pelvic organ prolapse and stress urinary incontinence.The pt and her attorney have alleged that as a result of these products being implanted in the pt, the pt has experienced pain, injury, and has undergone corrective surgery.A review of medical records indicated that on (b)(6) 2011, the pt underwent repair of a stage ii cystocele and rectocele and stress urinary incontinence, performed by dr.(b)(6) at (b)(6) healthcare.During this surgery, a biodesign surgisis tension-free urethral sling, a biodesign surgisis 4-layer tissue graft, a biodesign surgisis anterior pelvic floor graft, another mfr's titanium screws, and permanent ethibond suture.On (b)(6) 2012, the pt underwent an exam under anesthesia resection of vaginal polyp, resection of vaginal mesh eroded in the anterior aspect of the vagina, and a cystoscopy for the eval and treatment of her vaginal polyp, and eroded mesh/foreign body in the vagina and anterior uterine wall.The pt had previously presented to the office with increasing worsening inflammatory discharge, recurrent infections, bladder pain, and vaginal pain.Findings during the procedure included copious amounts of inflammatory discharge in the vagina.A polyp was present in the anterior mid portion of the vagina at the level of the sling and the most distal portion of any mesh that was used by the previous surgeon.The vagina was shortened from previous surgery.After the removal of the vaginal polyp and resection of the eroded mesh and suture material cystoscopy was performed that revealed a normal urethra, bladder, and patent ureters.During the procedure, once the polyp was removed, there was a defect and dimpling in the anterior aspect of the vagina that opened up in eroded ethibond suture material.Three sutures were removed.Once the 3 pieces of suture material was removed and sent off, eval revealed the mesh to be extruded from this opening.It was gently grasped and removed.There was no evidence of erosion posteriorly on eval.The extrusion happened only after the sutures were removed.The operative report did not describe if the graft removed was sent to pathology.A pathology report was not available.On (b)(6) 2012, the pt underwent another surgery due ot a vaginal polyp and eroded suture.The pt had a history of recurrent vaginal polyps and eroded sutures since having surgery by dr.(b)(6) in (b)(6) 2011.Since that time she had bladder issues, possible incontinence, vaginal discharge, and vaginal bleeding.During this (b)(6) 2012 procedure, eval at the base of the polyp revealed suture material.Once the polyp was removed, there was eroded suture material underneath which was also removed.Cystoscopy was normal; no suture material was noted inside the bladder.The excised suture material and polyp were sent for pathology.No pathology report was available.The following info was not provided by the complainant: specific info of the alleged injury; specific info regarding whether intervention was performed; specific info regarding why intervention was performed or what type / to what extent intervention was performed; specific correlation between device performance and alleged injury; and current pt status.

• Brand Name: BIODESIGN ANTERIOR PELVIC FLOOR GRAFT
• Type of Device: PELVIC FLOOR ANTERIOR
• Manufacturer (Section D): COOK BIOTECH; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 3675117
• MDR Text Key: 21273539
• Report Number: 1835959-2014-00009
• Device Sequence Number: 1
• Product Code: PAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/26/2014

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 Expiration Date: 06/30/2012
• Device Catalogue Number: J-PF-ANT-USL
• Device Lot Number: LB483419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2010
• 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
• Treatment: AMERICAN MEDICAL BONE SCREW ULTRA KIT,; J-SLH-4S-7X10, LOT# LB461345; J-STFK-8-2X40, LOT# LB457096; SUTURE; CATALOG# 72403886, LOT# 659612 AND
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 62 YR