MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS RETROPUBIC SLING SYSTEM; SURGICAL MESH

Model Number 5195612400

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Perforation (2001); Pocket Erosion (2013); Scar Tissue (2060); Scarring (2061); Shock (2072); Urinary Retention (2119); Prolapse (2475); Blood Loss (2597); No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated painful, permanent, severe and disabling injuries which were caused, aggravated, accelerated or lighted up by said occurrence, including pain, pelvic pain, abdominal pain, groin pain, leg pain, dyspareunia, mesh contraction, inflammation, scar tissue, bladder perforation, blood loss, neuropathic and other acute and chronic damage and pain, urinary incontinence, overactive bladder, incomplete bladder emptying, bladder spasms, urinary urge incontinence, recurrent infections and severe shock to nervous system, additional operations to locate and remove mesh, scarring, suspected erosion.

Manufacturer Narrative

Device code updated from 2976 to 2981 material twisted/bent.

Event Description

Additional information received 2/10/2021 states on (b)(6) 2018 partial excision of eroded supris [along with other non-coloplast products].Between (b)(6) 2018-(b)(6) 2019 recurrent sui, recurrent bacterial vaginosis, no evidence of erosion noted on office examination.Additional information received on (b)(6) 2021 states uterine prolapse, lower back pain and pelvic pain/pressure due to uterine prolapse, sui with activity/cough, some urinary frequency sui, grade 2 cystocele, grade 2 rectocele, moderate uterine prolapse, significant perineal relaxation with poor tone, perineum only 1 cm, bladder neck hypermobility.(b)(6) 2010 - da vinci robotic assisted: restorelle y/coloplast and gore-tex sutures used for sacral colpopexy, supracervical hysterectomy with left salpingo-oophorectomy.Dysuria, odorous urine, treated for uti (+) e.Coli but continues to have pelvic pressure, abdominal pain urine culture: (+) e.Coli, acute cystitis, , urinary frequency, incomplete emptying.(b)(6) 2018 - partial excision of eroded supris implant, cystoscopy x 2.Uti / acute cystitis (+) pseudomonas putida.(b)(6) 2018 - 1 mm supris exposure at mid-urethral incision with visible sutures.In-office partial excision of exposed supris/coloplast, excision of visible sutures.Pcp to ed - worsening abdominal/suprapubic pain x 4 days.Great discomfort s/p supris implant with no improvement in sui symptoms, discomfort now resolved but continued sui with activity/jump/sneeze.No signs of mesh erosion or suture exposure, failed supris/coloplast, sui.(b)(6) 2019 - examination under anesthesia, altis/coloplast implant, cystoscopy x 2.Persistent urinary incontinence, urinary frequency, dysuria, intermittent vaginal pain, inability to have intercourse due to dyspareunia.Extruded mesh, palpable mesh anteriorly/bunched up, tender to palpation, anterior vaginal scarring from sling, decreased anal sphincter tone.Exposure of vaginal mesh with subsequent vaginal pain, full incontinence of feces.(b)(6) 2019 - in-office perineal/endovaginal/endoanal imaging - thin band of restorelle y/coloplast comes down to urethrovesical angle with ~90 degree anal sphincter defect, severe levator ani/anal sphincter muscle deficiency with long-standing fecal incontinence, 2 slings - one seen distal and is roped shaped, one seen cephalad (anterior) and highly convoluted (coiled).(b)(6) 2020 - intraoperative ultrasound, examination under anesthesia, fascia lata harvest from left thigh, fascia lata and gore-tex sutures used for suburethral sling, extensive/meticulous dissection to remove extruded/exposed/adhered/eroded/intertwined (2, possibly 3) [gynecare tvt/ethicon, supris/coloplast, and possibly altis/coloplast] previously placed bladder slings, anterior repair with adjacent tissue transfer (2 cm x 6 cm), suprapubic catheter insertion, cystoscopy.Bloody urine, acute cystitis with hematuria.

• Brand Name: SUPRIS RETROPUBIC SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10393373
• MDR Text Key: 202514310
• Report Number: 2125050-2020-00640
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

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 Model Number: 5195612400
• Device Lot Number: 5799806
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 02/10/2021; 08/23/2022
• Supplement Dates FDA Received: 08/23/2022; 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• 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): Hospitalization; Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female