MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO PFR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Anxiety (2328); Depression (2361); Dysuria (2684); Dyspareunia (4505)

Event Date 11/30/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit was implanted into the patient during a procedure performed on (b)(6) 2010, for the treatment of pelvic organ prolapse.It was noted that during the same procedure, a partial hysterectomy was also performed.In or around 2014, the patient started having severe pelvic pain.The patient was incorrectly diagnosed with endometriosis causing the severe pain to become chronic.In or around 2016, the patient underwent an oophorectomy attempting to resolve her symptoms; however, no improvement was noted; this caused her severe depression and anxiety.The patient alleged that the chronic pain was dismissed.In or around (b)(6) 2022, the patient went to a clinic to determine the cause of her pain.During the visit, the patient learned the mesh was causing substantial inflammation and had caused an infected abscess in her pelvic region.On (b)(6) 2022, the patient underwent a surgical procedure to excise the mesh.The patient alleged to continue suffering severe pain and emotional distress as a result of the experience.It was indicated that the patient underwent pelvic floor physical therapy, lidocaine trigger point injections, botox injections, valium suppositories, and other therapies to address the ongoing pain.Through all of this, the patient noted difficulty doing her daily work activities, forcing her to take a medical leave of absence.The patient alleged not being able to sit or stand for long periods and not being able to sleep through the pain.The patient indicated the pain could be strong enough to cause vomit.Additionally, the patient noted overwhelming pain with sex and using the restroom.The experience and its effects on her health have also caused severe anxiety and depression.The patient noted a negative impact to her marriage and family life.Additionally, the patient indicated unnecessary expense, embarrassment, disfigurement, and harm.It was alleged that the patient may need to undergo additional surgery in the future and may continue to suffer significant pain, debilitating injuries, serious bodily injury, mental and physical pain and suffering, unnecessary medical expense for medical care, treatment, and therapies long into the future.

Manufacturer Narrative

Blocks d4, h4: the suspect device lot number is unknown; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2330- pain, e1906 - infection, e1301 - dysuria, e2326 - inflammation, e1405 - dyspareunia.The following imdrf impact code capture the reportable event of: f1905 - revision, f1202 - disability.

• Brand Name: CAPIO PFR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19033657
• MDR Text Key: 339261501
• Report Number: 2124215-2024-18576
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Sex: Female