MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD VAGINAL SUPPORT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M006831708

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

Patient Problems Headache (1880); Pain (1994); Vomiting (2144); Anxiety (2328); Depression (2361); Prolapse (2475); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/03/2014

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported that an uphold vaginal support system and solyx sis system devices were implanted into the patient during a sacral spinous ligament fixation + vault suspension + uphold mesh graft for repair + solyx for hypermobility of the urethra procedure performed on (b)(6) 2014 for the treatment of grade iii anterior vaginal wall prolapse with grade ii uterine prolapse.On (b)(6) 2019, the symptoms of dyspareunia, mixed stress and urge urinary incontinence, myofascial muscle pain and pelvic pain were noted.The patient also experienced problems like anxiety, chronic back pain, chronic constipation, depression, fibromyalgia, hyperlipidemia, migraine, postoperative nausea and vomiting.On (b)(6) 2019, the patient underwent vaginal urethrolysis, mesh sling (solyx) removal, 50 units botox injection and kelly plication and anterior colporrhaphy.During mesh removal, a scarring underneath the urethra and inflammation around mesh were noted.It was also found that the sling was too close to the bladder neck and on the left side of the patient, there was dense scar and looks like the sling was partially through the periurethral tissue.Body tissue grew into the mesh, so it was generally impossible to remove all of the mesh that was placed during the original sling procedure.Patient awoken from anesthesia and transferred stable to postoperative recovery room.No complications.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported that an uphold vaginal support system and solyx sis system devices were implanted into the patient during a sacral spinous ligament fixation + vault suspension + uphold mesh graft for repair + solyx for hypermobility of the urethra procedure performed on (b)(6) 2014 for the treatment of grade iii anterior vaginal wall prolapse with grade ii uterine prolapse.On (b)(6) 2019, the symptoms of dyspareunia, mixed stress and urge urinary incontinence, myofascial muscle pain and pelvic pain were noted.The patient also experienced problems like anxiety, chronic back pain, chronic constipation, depression, fibromyalgia, hyperlipidemia, migraine, postoperative nausea and vomiting.On (b)(6) 2019, the patient underwent vaginal urethrolysis, mesh sling (solyx) removal, 50 units botox injection and kelly plication and anterior colporrhaphy.During mesh removal, a scarring underneath the urethra and inflammation around mesh were noted.It was also found that the sling was too close to the bladder neck and on the left side of the patient, there was dense scar and looks like the sling was partially through the periurethral tissue.Body tissue grew into the mesh, so it was generally impossible to remove all of the mesh that was placed during the original sling procedure.Patient awoken from anesthesia and transferred stable to postoperative recovery room.No complications.

Manufacturer Narrative

Block h2: h6: patient codes e0116 and e2401 have been added to capture the events of migraine without aura and without status migrainosus and hyperlipidemia.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision surgery physicians are: (b)(6).Block h6: patient codes e1405, e2330 capture the reportable events of dyspareunia, pain.Impact code f1905 captures the reportable event of revision surgery.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: UPHOLD VAGINAL SUPPORT SYSTEM
• 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
• MDR Report Key: 12380267
• MDR Text Key: 268667060
• Report Number: 3005099803-2021-04317
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M006831708
• Device Catalogue Number: 831-708
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 67