MAUDE Adverse Event Report: BALLYMONEY - USS UNKNOWN IVS TUNNELLER DEVICE; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN IVS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Abnormal Vaginal Discharge (2123); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Pre-operative diagnosis: pelvic pain; hydrosalpinx; significant pelvic relaxation; stress urinary incontinence.Post-operative diagnosis: pelvic pain; hydrosalpinx; significant pelvic relaxation; stress urinary incontinence; plus sigmoid diverticulum.Surgery: (b)(6) 2005.Pre and post-operative diagnosis: periurethral abscess/infection.Name of procedure: periurethral sinus tract.Surgery: (b)(6) 2005.Pre and post-operative diagnosis: paravaginal sinus tracts; infected suprapubic sling.Name of procedure: exploration of the space of retzius with salvage irrigation of the space of retzius; and excision and closure of vaginal sinus tracts.Surgery: (b)(6) 2005.Pre and post-operative diagnosis: stress urinary incontinence.Name of procedure: sling urethropexy; monarch obturator sling; and cystoscopy.

Manufacturer Narrative

(b)(4).

Event Description

(b)(6) 2016: patient complaints of wound on buttock, has a large decubitus bed sore that is located over the bladder pacemaker.Alleged failed bladder slings led to the pacemaker.(b)(6) 2016: underwent removal of exposed pacemaker with removal of wire and debridement of wound packing under general anesthesia for removal exposed pacemaker from the bladder.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.Pre-operative diagnosis: pelvic pain; hydrosalpinx; significant pelvic relaxation; stress urinary incontinence.Post-operative diagnosis: pelvic pain; hydrosalpinx; significant pelvic relaxation; stress urinary incontinence; plus, sigmoid diverticulum.Pre and post-operative diagnosis: urethral diverticulum.Name of procedure: excision of urethral diverticulum and closure of urethral defect.Surgery:(b)(6)05.Pre and post-operative diagnosis: peri-urethral abscess/infection.Name of procedure: peri-urethral sinus tract.Surgery: (b)(6) 2005.Pre and post-operative diagnosis: paravaginal sinus tracts; infected suprapubic sling.Name of procedure: exploration of the space of retzius with salvage irrigation of the space of retzius; and excision and closure of vaginal sinus tracts.Surgery: (b)(6) 2005.Pre and post-operative diagnosis: stress urinary incontinence.Name of procedure: sling urethropexy; (b)(4) obturator sling; and cystoscopy.Surgery: (b)(6) 2016.Pre and post-operative diagnosis: exposed pacemaker from the bladder, right butt cheek.Name of procedure: removal of exposed pacemaker with removal of wire and debridement of would with packing.Office visit: (b)(6) 2016.Large decubitus bed sore that is located over a bladder pacemaker.There since (b)(6) and started after a fall.Patient has had failed bladder slings that eventually led to the pacemaker.Reason for mesh implantation: pelvic pain, hydrosalpinx, significant pelvic relaxation, stress urinary incontinence.Procedure (s) performed: right oophorectomy along with placement of 2 ivs tunneler sling and pelvicol mesh.Complications post ivs tunnelers and pelvicol implantation: (interim gynecological medical records from the time period (b)(6) 2003 ¿ (b)(6) 2004 are not available for review).(b)(6) 2004: urethral diverticulum (indirect information taken from the pre- operative diagnosis of operative report dated on (b)(4) 2004).Complications post interventional surgery: (interim gynecological medical records from the time period (b)(6) 2004 ¿ (b)(6) 2005 are not available for review).(b)(6) 2005: periurethral abscess/infection (indirect information taken from the preoperative diagnosis of operative report dated on (b)(6) 2005).Complications post second interventional surgery details: (b)(6) 2005: she had extrusion of the vaginal sling which was excised (corresponding records not available).She has paravaginal sinus tract, infected suprapubic sling (indirect information taken from the indications and pre- operative diagnosis of operative report dated on (b)(6) 2005).Complications post third interventional surgery (b)(6) /2005: stress urinary incontinence (indirect information taken from the indications and pre- operative diagnosis of operative report dated on (b)(6) 2005).Complications post additional implant (mon arc sling) surgery: (interim gynecological medical records from the time period (b)(6) 2005 ¿ (b)(6) 2016 are not available for review).(b)(6) 2016: patient complaints of wound on her buttock, she has a large decubitus bed sore that is located over the bladder pacemaker (corresponding records not available) failed bladder slings that eventually led to the pacemaker spoke with dr.(b)(6) who feels the implant needs to stay in place if possible.As, such, excision of the ulcer and the closure either primarily or with a local flap would offer the best chance of keeping the pacemakers its current location, possibility of having to relocate the implant.(b)(6) 2016: exposed pacemaker from the bladder, right butt cheek.(indirect information taken from the pre- operative diagnosis of operative report dated on (b)(6) 2016).Reason for mesh implantation: pelvic organ prolapse with enterocele, stress urinary incontinence and hypermobile urethra.Procedures performed: enterocele closure with graft with vaginal vault suspension using sling, anterior colporrhaphy, transobturator sling urethropexy, cystoscopy and perineorrhaphy.Complications post and ivs tunneler implantation: (interim records from (b)(6) 2006 to (b)(6) 2006 are not available to know the complications post implant surgery).(b)(6) 2006: a mass in her left groin with purulent discharge, a small lesion on her left buttocks - she continually scrapes the surface causing it to bleed ¿ pelvic examination revealed a hard mass lateral to be vulva, on the left side, most likely represents a sebaceous gland or folliculitis - buttocks have one small erythematosus area on the left side - skin lesion of the left groin, skin lesion of the left buttocks - scheduled for immediate surgery.Complications post first interventional surgery: (interim records from (b)(6) 2006 to (b)(6) 2011 are not available to know the complications post interventional surgery).: anginal examination rev revealed mesh like material palpable and visible at vaginal apex consistent eroded material from her surgery ¿ vaginitis secondary to questionable eroded mesh from vault suspension - referred to dr.(b)(6) for evaluation and treatment (b)(6) 2011: complains of , voiding difficulty has to lean forward, sensation of incomplete emptying, use pads for discharge - vaginal examination revealed mesh extrusion right apex appears to be dermal or allograft material - planned for mesh removal, adjacent organ injury.(b)(6) 2011: vaginal pain, weak urine stream - scheduled for cystoscopy and removal of vaginal mesh extrusion on (b)(6) 2011 with dr.(b)(6).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN IVS TUNNELLER DEVICE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BALLYMONEY - USS; 20 garryduff road; ballymoney co.; antrim ; EI
• Manufacturer (Section G): BALLYMONEY - USS; 20 garryduff road; ballymoney co.; antrim ; EI
• Manufacturer Contact: lisa hernandez ; north haven, CT 06473 ; 34925563
• MDR Report Key: 6234029
• MDR Text Key: 64205603
• Report Number: 6000141-2017-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

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: Health Professional
• Device Model Number: UNKNOWN IVS
• Device Catalogue Number: UNKNOWN IVS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; 01/20/2017; 08/08/2018
• Supplement Dates FDA Received: 03/14/2017; 07/17/2018; 10/05/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR