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

Model Number M0068317080

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

Patient Problems Erosion (1750); Pain (1994); Burning Sensation (2146); Prolapse (2475); Urinary Incontinence (4572)

Event Date 07/23/2009

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2009, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision surgery physicians are: (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

It was reported to boston scientific corporation that an uphold vaginal support system was implanted into the patient during an uphold vaginal support system to treat a vaginal vault prolapse and cystocele on (b)(6) 2009.After the procedure, the patient complaints of vaginal prolapse.Reportedly, the protrusion worsens when the patient strains and has been trying to avoid straining since noticing it.Additionally, the patient complains of pain, vaginal burning and discomfort.On (b)(6) 2020, the patient underwent a combined anterior and posterior repair with enterocele repair, bilateral uterosacral ligament suspension, removal of anterior vaginal wall mesh and tvt sling placement.During the procedure, a bilateral spill of urine from both ureters were observed.Reportedly, no evidence of intravesical foreign body was noted.The vaginal mesh was then removed from the vesico-vaginal septum.The mesh was dissected off of the anterior and posterior connective tissue and dissected it out laterally as far as possible.A permanent synthetic vaginal sling was then placed over a dilator and closed the vaginal mucosa.The patient was taken to recovery room in stable condition.

Manufacturer Narrative

Block h2: correction blocks b5 and h6 have been updated based on the review of the medical records on september 1, 2021.Block b3 date of event: date of event was approximated to (b)(6) 2009, implant date, as no event date was reported.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: dr.(b)(6).(b)(6).The revision surgery physicians are: dr.(b)(6).Dr.(b)(6).(b)(6).Block h6: patient codes 9205 and e2006 capture the reportable events of pain and extrusion.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.

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was implanted into the patient during an uphold vaginal support system to treat a vaginal vault prolapse and cystocele on (b)(6) 2009.On (b)(6) 2020, the patient reported vaginal prolapse.She says she felt it in the shower earlier that week and then saw something sticking out.Reportedly, the protrusion worsens when the patient strains and has been trying to avoid straining since noticing it.Additionally, the patient complains of pain, vaginal burning and discomfort.Exam findings revealed a grade 3 cystocele, grade 1 enterocele, grade 2 rectocele, and anterior vaginal wall pain where previous mesh kit is placed.The assessment was vaginal vault prolapse, posthysterectomy and mixed urinary incontinence.On (b)(6), 2020, the patient underwent a combined anterior and posterior repair with enterocele repair, bilateral uterosacral ligament suspension, removal of anterior vaginal wall mesh and tvt sling placement.Preoperative diagnoses included post-hysterectomy vaginal vault prolapse, mixed urinary incontinence, pelvic pain.Operative findings included a small band of embedded mesh along the anterior vaginal wall.During the procedure, a bilateral spill of urine from both ureters were observed.Reportedly, no evidence of intravesical foreign body was noted.The vaginal mesh was then removed from the vesico-vaginal septum.The mesh was dissected off of the anterior and posterior connective tissue and dissected it out laterally as far as possible.A permanent synthetic vaginal sling was then placed over a dilator and closed the vaginal mucosa.The patient was taken to recovery room in stable condition.

• 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: 12376528
• MDR Text Key: 268425338
• Report Number: 3005099803-2021-04351
• 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: 09/27/2021

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 Model Number: M0068317080
• Device Catalogue Number: 831-708
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 09/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR