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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Erythema (1840); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Swelling (2091); Abnormal Vaginal Discharge (2123); Sleep Dysfunction (2517); Lethargy (2560); Dysuria (2684); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Increased Sensitivity (4538); Urinary Incontinence (4572)

Event Date 09/27/2018

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 intense pain and swelling in vagina, eroded mesh in the vaginal vault, surrounding tissues and organs.Removal of mesh on (b)(6) 2018 by (b)(6).Only a partial removal was performed during this procedure.Intractable pain in the pelvis, vagina, perineum, groin, and left leg.2nd surgery by (b)(6) on (b)(6) 2019 to remove all mesh components.The remnants could not be located.Chronic inflammation and nerve injury from the sling and mesh.Pain is permanent and affects the pelvis, vagina, perineum, groin, and leg.Unable to have sexual relations, unable to sit, walk, or stand normally, and unable to ride a bike.Diagnosed with pudendal and obturator neuralgia caused by implantation of the altis sling and requires therapeutic injections, pelvic floor physical therapy, and medication management for pain relief.Physical scarring of the abdomen and vagina, bladder dysfunction.

Event Description

This follow-up mdr is created to document the additional event information received for record #604750.This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint, the device not being returned for evaluation and the lot number not being provided, a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

Manufacturer Narrative

Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.

Event Description

Additional information further reported that between 23oct2018 and 15nov2019, the patient experienced pain with palpation of levator muscles, ½ cm mesh erosion left of the urethra, vaginal pain with malodorous vaginal discharge and high-tone pelvic floor dysfunction with myofascial pelvic pain, urinary urgency, pulling sensation and pain at the perineum, 1.5 cm of mesh exposure on both the left and the right.Dysuria, vulvovaginitis, vulvar erythema and skin breakdown, persistent myofascial pain, removal of altis sling due to inflammatory reaction.Vaginal inflammation, posterior fourchette and vulva tenderness, severe pelvic pain behind pubic bone that radiates to back and worsens with activity, skin irritation, minimal incontinence.Mesh revision 6/26/2019 with cystoscopy and excision of vaginal cyst and laparoscopic ovarian cyst excision.Pain in the left groin, pelvic and vaginal pain.

Manufacturer Narrative

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

Event Description

Additional information received further reported the patient experienced right lower back pain, buttock and hip pain, pain down the left leg, deep and chronic pelvic pain and muscle spasticity.

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

Additional information received reported that the patient underwent a device excision surgery with closure of periurethral defects, reinforcement of midline suburethral fascia, and cystoscopy (2) on (b)(6) 2018 which revealed significant sling erosions, erythematous suburethral mucosa, and thinning midline suburethral fascia.The patient was seen in the emergency department on (b)(6) 2019 for chronic pelvic pain, lethargy, abdominal pressure, and occasional stress urinary incontinence.

Manufacturer Narrative

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

Event Description

Additional information received on (b)(6) 2022 as follows: patient is experiencing urinary incontinence, dyspareunia with penetration and nocturia.

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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10462958
• MDR Text Key: 210463177
• Report Number: 2125050-2020-00778
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/28/2023

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 Expiration Date: 06/05/2021
• Device Model Number: 5196502400
• Device Lot Number: 6163904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 07/28/2020; 02/10/2021; 05/20/2021; 06/15/2022; 10/23/2022; 09/15/2023
• Supplement Dates FDA Received: 10/29/2020; 03/10/2021; 06/16/2021; 06/21/2022; 10/29/2022; 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2018
• 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): Hospitalization; Required Intervention; Other
• Patient Sex: Female