MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC COAPTITE INJECTABLE IMPLANT; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

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

Patient Problem Calcium Deposits/Calcification (1758)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, calcified/ stones (injection site calcification) was deemed to meet the serious criteria of required intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not reported.

Event Description

This mdr is related to mdr 3013840437-2022-00013 referring to the same patient.This consumer report was received from a us lawyer and concerns a female patient.She was injected with coaptite, as an urethrolysis/extensive transvaginal urethrolysis (as reported), on (b)(6) 2016.The patient had significant complications.She has a neurogenic bladder with poor bladder contractility, urgency and urgent incontinence/ urinary incontinence.She had a prior sling procedure that resulted in urinary retention because there was a neuropathic dysfunction, with significant scoliosis and the right hand that was not usable for any fine manipulation.She was unable to do self-catheterization.After the coaptite injection, the patient experienced a recurrent urinary infection and sepsis, and complications of a mesh surgery, requiring removal for obstruction.As reported, she had post creation of a continent augmentation using an appendix with incontinence.As reported, the urethrolysis and also the sling procedure failed to maintain continence.Also because of the small bladder capacity and inability to urinate, it was decided to perform a cecum cystoplasty, with the appendix being the continent stoma.The cystoscopy showed no evidence of a stone or tumors in the bladder, but on an ultrasound and ct scan, there were multiple areas of prior coaptite injection that now calcified, grew in size, and were inside the urethral wall.The only solution to eliminate the source of infection and stones was a urethrectomy.Also, it was planned to repair the stoma, and if required, take a new segment of the bowel.As reported, she received a transvaginal excision of a urethrectomy, anterior vaginal wall reconstruction, creation of a left in situ martius flap, exploratory laparotomy, revision of continent stoma (appendix) with tapering and reposition and a plication of the ileocecal valve around the base of the appendix.The outcome of the events was unknown.Internal database correction performed on 17-feb-2022: device issue was deleted, as it was not reported that the device was damaged/defective, the device procode was amended and the initial narrative and medical assessment were updated.Follow-up information was received on 11-feb-2022: the patients pre/postoperative diagnosis was confirmed as recurrent urinary infections and sepsis, urinary incontinence, post creation of a continent augmentation using an appendix with incontinence, neurogenic bladder, with poor bladder contractility, complications of mesh surgery, requiring removal for obstruction and post partial sling (failed).The name of the operation was also confirmed as extensive transvaginal urethrolysis, transvaginal excision of a urethrectomy, anterior vaginal wall reconstruction, creation of a left in situ martius flap, exploratory laparotomy, revision of continent stoma (appendix), with tapering and reposition and plication of the ileocecal valve around the base of the appendix.The outcome of the events remained unchanged.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 13580684
• MDR Text Key: 290463758
• Report Number: 3013840437-2022-00022
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2022

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
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 02/22/2022
• 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
• Treatment: CONCOMITANT DRUG NOT AVAILABLE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female