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

Catalog Number J-PF-ANT-SSL

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The pt was reportedly implanted with a biodesign surgisis vaginal erosion repair graft and a boston scientific solyx system on (b)(6) 2011, an unspecified surgisis graft and a bard ajust on (b)(6) 2012, and a biodesign surgisis anterior pelvic floor graft on (b)(6) 2013.The pt and her attorney have alleged that as a result of these products being placed in the pt, the pt has experienced pain, injury, and has undergone corrective surgery.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; current pt status.

Manufacturer Narrative

Conclusion: root cause inconclusive.This mdr is related to mdr 1835959-2014-00011 and mdr 1835959-2014-00012.A review of medical records indicated that on (b)(6) 2011, the pt underwent a diagnostic hysteroscopy with anterior colporrhaphy using surgisis and placement of a transobturator tape with solyx, performed by dr.(b)(6) at (b)(6) hospital, for treatment of her mixed urinary incontinence and cystocele.An (b)(6) 2011 two week post-operative appointment indicated, the pt had tremendous improvement in her urinary incontinence but she still experienced urinary urgency.A (b)(6) 2011 appointment indicated that at the pt's 6 week post-operative appointment, she was started on medication for help with her mixed incontinence.There was discussion of the pt's coughing episodes causing increased intra-abdominal pressure likely being the cause of her recurrent incontinence.The pt had a urodynamics study on (b)(6) 2012 which was negative.The pt had office visits on (b)(6) 2012 and (b)(6) 2012 for re-eval of her urinary incontinence.On (b)(6) 2012, the pt expressed concern over her vaginal bleeding and pressure from her uterus.On (b)(6) 2012, the pt underwent a vaginal hysterectomy with anterior colporrhaphy, sacrospinous ligament fixation, and placement of transobturator tape with cystoscopy, performed by dr.(b)(6) at (b)(6) hospital, for the treatment of her menorrhagia, uterine prolapse, cystocele, and mixed urinary incontinence.No documents were available for 2013.Investigation - eval: investigation into this claim included a review of the claim allegations, a review of the cbi complaint system, a review of the device history records which indicated the product was manufactured to specifications, a review of the biodesign surgisis anterior pelvic floor graft ifu fp0040-01d and other communication and investigation into this report/claim is being handled by our attorney.Summary of investigation findings: no details were provided relating to the (b)(6) 2013 surgery.After reviewing the details received, 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 o 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.Based on the info provided by the complainant, details regarding a specific correction between the biodesign surgisis anterior pelvic floor graft's performance and the alleged injury remain unk.A root cause of the claim allegations is inconclusive.All other matters relating to this litigation are being handled by our attorney.If/when additional info is obtained a follow-up mdr will be filed.

• 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: 3675113
• MDR Text Key: 21488793
• Report Number: 1835959-2014-00013
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130006
• 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: 10/31/2014
• Device Catalogue Number: J-PF-ANT-SSL
• Device Lot Number: LB630830
• 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: 04/17/2013
• 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: BOSTON SCIENTIFIC SOLYX SYSTEM LOT # 1ML0110103; BARD AJUST LOT # HUWF 1501
• Patient Outcome(s): Disability