MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Catalog Number 720093-01

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Incontinence (1928); Pain (1994); Scarring (2061); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Fibrosis (3167)

Event Date 02/24/2010

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated june 30, 2014 under (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced recurrent stress incontinence, mixed urinary incontinence, difficulty voiding, bladder neck obstruction, incomplete bladder emptying, dribbling urination, urethral fibrosis, recurrent anterior vaginal wall prolapse, and scarring.It was also reported that the plaintiff allegedly experienced pain.There was a revision of the mesh on (b)(6) 2010 and the device was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death reported were aspiration of vomitus, developing ilius, chronic obstructive pulmonary disease, hypertension and coronary artery disease and stroke.Related to mfr # 2183959-2015-00607.

• Brand Name: AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5335574
• MDR Text Key: 34689424
• Report Number: 2183959-2015-00606
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/03/2012
• Device Catalogue Number: 720093-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2015
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2009
• 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: SOLYX SYSTEM
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 98