MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR; SURGICAL MESH

Model Number 5014502400

Device Problem Migration (4003)

Patient Problems Erosion (1750); Nausea (1970); Pain (1994); Scar Tissue (2060); Skin Erosion (2075); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Vomiting (2144); Burning Sensation (2146); Urinary Frequency (2275); Prolapse (2475); Intermenstrual Bleeding (2665); Dysuria (2684); Kidney Infection (4502); Dyspareunia (4505)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, legal representative stated the patient was implanted with a 30x30 cm device and a device from another manufacturer on (b)(6) 2016.The doctor dissected through the patient's vagina at the level of the mid-urethra and implanted the other manufacturers device transvaginally using trocars that were provided in the other manufacture's kit.The doctor used the trocars to force the other manufacture's device from the vaginal incisions into the suprapubic incisions.The tape was then brought out through the skin incisions during cystoscopy.The device was tensioned, the plastic sheath was removed, and the device was cut at the level of the skin.During the implant procedure, the doctor cut the 30x30cm device into a 24x6cm strip and implanted the device through the vagina for correction of the patient's posterior pelvic organ prolapse.The proximal portion of the device was left in the rectovaginal space for retrieval later in the procedure.After suturing the device transvaginally, the da vinci robot via abdominal dissection was used to access the device left in the patient's posterior compartment during the transvaginal portion of the procedure.The doctor located and delivered the posteriorly placed device into the pelvis and anchored the posterior device to the posterior vagina.The fixation extended out the lateral vaginal at the level of the uterosacral ligaments.A similar size piece of the device (24x5cm) was introduced abdominally using the da vinci robot to correct the patient's anterior pelvic organ prolapse.The doctor anchored the device for the anterior repair to the anterior vagina with fixation extending distally to the level of the bladder neck, laterally to the lateral vagina, and apically to the apex of the anterior vagina.The doctor then joined the two large pieces of device by grasping both pieces, fashioning them over the patient's sacrum and anchored both pieces of device together to the sacral promontory.The patient returned to the operating room for a revision surgery on april 3,2017.During the procedure, the doctor performed a bilateral salpingooopherectomy and then addressed the other manufacturer's device.According to the operative note, the doctor identified the prior other manufacturers device had "freed and mobilized [it] away from the vagina and also away from the overlying urethra." the doctor implanted a second other manufacturer's device.The second other manufacturers device was placed with increased tension and was lying slightly proximal to the previously placed device.The patient reported experiencing erosion, pain, device removal procedures, and surgeries.The patient returned to the operation room for a second revision performed by the doctor on october 1, 2018.During this procedure, the doctor implanted a device vaginally to correct anterior prolapse.The patient returned to the operation room for a third revision performed by the doctor on november 2, 2018.Prior to the procedure, the patient was experiencing incomplete bladder emptying.During this procedure, the patient removed one of the prior other manufacturer's devices from sulci to sulci.According to the operative note, the device was fully mobilized laterally, then transected and then freed from the overlying urethra, then excised lateral to the sulci bilaterally.The patient returned to the operating room for a fourth revision performed by the doctor on october 19, 2019.The patient preoperative diagnosis for this surgery was dyspareunia and nonspecific lower pelvic pain following prior vaginal device repair.The diagnoses were confirmed during the procedure.The doctor performed a revision of the anterior vaginal device and subsequent anterior repair with cervicopexy.During this procedure, the doctor identified the device, and removed using a dissection that extended laterally to expose the path of the device towards the sacrospinous ligaments.The doctor took the distal section to the level of the bladder neck in removing device.The doctor used a non-polypropylene biologic graft to reduce the bladder prolapse that was caused from removal of the device.On october 20, 2020, the patient returned to the operating room for a fifth revision, this revision procedure was performed by a different doctor.Prior to this revision surgery, the doctor diagnosed the patient with dyspareunia, sexual pain, and vaginal wound after anterior vaginal device and biologic graft surgeries.The doctor confirmed these diagnoses post-op.During the procedure, the doctor removed additional portions of the device placed anteriorly and sutured the vaginal wound.The doctor found transverse anterior vaginal wall banding with dyspareunia, sexual pain, and vaginal scarification.According to the pathology records, 5 cm x 5 cm in aggregate of device was removed during this procedure.

Event Description

Additional information received on 9/19/2023 indicates the patient was experiencing, urinary frequency, urinary tract infections, bleeding after intercourse, dysuria, a burning sensation, vaginal discharge and mesh exposure was observed.

Event Description

Additional information received on 11/6/2023 provides patient symptoms as follows: nausea and vomiting.

Manufacturer Narrative

Corrections: item number, lot number, udi number, catalogue number.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15587200
• MDR Text Key: 301568570
• Report Number: 2125050-2022-01061
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 05708932484022
• UDI-Public: 05708932484022
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Device Lot Number: 5925687
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2023
• Date Device Manufactured: 11/30/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR