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 Material Integrity Problem (2978)

Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Inflammation (1932); Scar Tissue (2060)

Event Date 07/26/2011

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6), 2011, the date the sling was implanted, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: (b)(6).The revision surgeon is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was implanted during an anterior repair with uphold mesh, posterior repair, cystoscopy, and perineoplasty procedure performed on (b)(6), 2011.The patient had rectocele, cystocele, and uterine prolapse.Post-operative findings showed a grade iii cystocele and a grade ii rectocele with a gaping introitus.On cystoscopy, there was bilateral fill and spill of the ureteral orifices with blue dye into the bladder and no evidence of mesh or bladder defect.On (b)(6) 2017, the patient underwent excision of a vaginal foreign body (permanent suture), excision of granulation tissue, and unplanned excision of vaginal mesh.The patient had a previous mesh procedure placed at an outside hospital.She had undergone resection of some of the mesh at a different outside hospital, and for the last 4 years she had vaginal bleeding that had been addressed by multiple clinicians in the clinic setting.Furthermore, there was extensive vaginal granulation tissue at the patient's right apex of the vagina just lateral to the cervix, and a braided foreign body suture was also observed.The patient had a mesh contraction in the midline and a mesh erosion in the midline, but these were not symptomatic.The patient was desirous of addressing just the part of the procedure that was contributing to her vaginal bleeding, her biggest complaint.Additionally, the specimens, including the excised suture, granulation tissue, and mesh, were sent to pathology.On (b)(6), 2018, the patient underwent vaginal excision of mesh and granulation tissue, requiring one and a half hours of dissection.The patient who had chronic granulation from a foreign body was thought to have only a permanent suture; however, upon removing this permanent suture, it was discovered that she had an extensive mesh, and the most superficial vaginal mesh was excised to prevent her symptoms from worsening with postmenopausal bleeding.The mesh and granulation tissue erosion recurred and extensive mesh with erosion and tightening across the entire vaginal apex were felt.Therefore, the second vaginal mesh excision was done on the patient.In addition, the multiple excised pieces of mesh were sent to pathology.

Manufacturer Narrative

Block h11: block h5 patient code has been corrected.Block b3 date of event: date of event was approximated to (b)(6) 2011, the date the sling was implanted, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).(b)(6).The revision surgeon is: dr.(b)(6).(b)(6).Block h6: patient codes e2006, e2326 and e0506 capture the reportable events of erosion (foreign body in vagina), inflammation (granulation tissue) and hemorrhage/bleeding (vaginal bleeding).Impact code f1905: device revision or replacement has been used to capture excision of vaginal mesh.

Event Description

It was reported to boston scientific corporation that an uphold vaginal support system was implanted during an anterior repair with uphold mesh, posterior repair, cystoscopy, and perineoplasty procedure performed on (b)(6) 2011.The patient had rectocele, cystocele, and uterine prolapse.Post-operative findings showed a grade iii cystocele and a grade ii rectocele with a gaping introitus.On cystoscopy, there was bilateral fill and spill of the ureteral orifices with blue dye into the bladder and no evidence of mesh or bladder defect.On (b)(6) 2017, the patient underwent excision of a vaginal foreign body (permanent suture), excision of granulation tissue, and unplanned excision of vaginal mesh.The patient had a previous mesh procedure placed at an outside hospital.She had undergone resection of some of the mesh at a different outside hospital, and for the last 4 years she had vaginal bleeding that had been addressed by multiple clinicians in the clinic setting.Furthermore, there was extensive vaginal granulation tissue at the patient's right apex of the vagina just lateral to the cervix, and a braided foreign body suture was also observed.The patient had a mesh contraction in the midline and a mesh erosion in the midline, but these were not symptomatic.The patient was desirous of addressing just the part of the procedure that was contributing to her vaginal bleeding, her biggest complaint.Additionally, the specimens, including the excised suture, granulation tissue, and mesh, were sent to pathology.On (b)(6) 2018, the patient underwent vaginal excision of mesh and granulation tissue, requiring one and a half hours of dissection.The patient who had chronic granulation from a foreign body was thought to have only a permanent suture; however, upon removing this permanent suture, it was discovered that she had an extensive mesh, and the most superficial vaginal mesh was excised to prevent her symptoms from worsening with postmenopausal bleeding.The mesh and granulation tissue erosion recurred and extensive mesh with erosion and tightening across the entire vaginal apex were felt.Therefore, the second vaginal mesh excision was done on the patient.In addition, the multiple excised pieces of mesh were sent to pathology.

• 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
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15382297
• MDR Text Key: 299508443
• Report Number: 3005099803-2022-05086
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: M0068317080
• Device Catalogue Number: 831-708
• Device Lot Number: 1ML1022205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female