MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.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, the patient experienced serious bodily injuries, including but not limited to, voiding dysfunction, pain, dyspareunia, foreign body reaction, other injuries, and permanent injury.The patient had undergone medical treatment and will likely undergo future medical treatment and procedures.

Event Description

Additional information received further reported that o the following dates, the patient was experiencing or had experienced the following: (b)(6) 2021: laparoscopic robotic-assisted urethrolysis and normalization of the posterior space of retzius.Found to have significant scarring as well as a palpable sling with some obstruction.Complaints of positional voiding and discomfort.(b)(6) 2019: vaginal granulation tissue.(b)(6) 2020: dyspareunia, pain with certain activities, occasional urinary leakage with small positional/pressure changes.Some palpable superficial altis on exam (reproduces pain symptoms when palpated), left arm of sling tender to palpation.Altis erosion, pelvic pain, mixed urinary incontinence, urinary retention, positional voiding, significant urinary urgency is consistent with altis being somewhat obstructive.(b)(6) 2020 - (b)(6) 2020: vaginal pain, coccyx pain (coccydynia), voiding dysfunction, positional voiding, pelvic pain.States she would like surgical intervention as her goals are to be pain free or reduced, able to engage in sexual intercourse, and reduced lower urinary tract symptoms.Complete removal of altis with removal of bilateral anchors, pubovaginal sling implant (rectus fascia used), vaginal mucosa trimming/freshening with defect closure, amniofill/mimedx application, bladder irrigation, cosmetic excision of redundant lower abdominal tissue, steroid injections to right coccyx/perirectal space, cystoscopy.Intraoperative findings: altis had largely separated from right attachment and was significantly contracted to the left with obstructive component as evidenced by grade 1-2 bladder trabeculations with crystal formation consistent with incomplete bladder emptying, thinning of urethral tissue consistent with altis contraction, grade 1 cystocele, grade 1 apical prolapse, grade 1 rectocele, ethibond sutures found in midline abdominal area consistent with prior abdominal procedure.

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usauv autumn valentine ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10726541
• MDR Text Key: 212723753
• Report Number: 2125050-2020-00997
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5094534
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2021
• 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: 52 YR
• Patient Sex: Female