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

Model Number M0068317170

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

Patient Problems Erosion (1750); Dyspareunia (4505)

Event Date 01/31/2014

Event Type  Injury  

Event Description

Note: this report pertains to one of five devices implanted into the same patient.Refer to manufacturer report # 3005099803-2022-05852 and 3005099803-2022-05854 for the associated device information.Please note that the for the remaining two devices, per the repliform - lifecell corporation, boston scientific does not have a regulatory/contractual obligation to report on this device.It was reported to boston scientific corporation that an obtryx system - halo and a repliform sling were used during a total vaginal hysterectomy, repair of rectocele with graft, transobturator midurethral sling, sacrospinous vaginal vault fixation, cystoscopy and repair of old obstetrical labial tear procedures performed on (b)(6) 2008 to treat a patient with pelvic relaxation syndrome, rectocele, stress urinary incontinence, and old obstetrical labial tear.There were no complications during the implant procedure.The patient was taken to the post anesthesia recovery room in satisfactory condition with vital signs stable.On (b)(6) 2013, the patient was experiencing pelvic pain and stress urinary incontinence.In addition, it was noted that the patient have adhesions, cystocele, rectocele, vaginal wall prolapse and bilateral cystic ovaries.The patient underwent laparoscopy with bilateral salpingo-oophorectomy and lysis of adhesions, repair of cystocele with graft augmentation (uphold), repair of rectocele with graft augmentation (repliform), sacrospinous ligament fixation, transobturator midurethral sling (obtryx), and cystoscopy.During the procedure, the patient was taken to the operating room and placed on the table in supine position.Under adequate general anesthesia, she was placed in lithotomy position with the area prepped and draped in sterile fashion and the bladder had been catheterized with foley catheter.Sponge with a sponge stick was inserted in the vagina for identification of the vaginal cuff.Under sterile fashion, an infraumbilical incision was made.This incision was taken down through subcutaneous tissue to the fascia.The fascia was incised and the peritoneum was entered near away from the bowel.The hasson cannula was inserted and secured in the usual fashion to the fascia.The upper and midabdomen appeared to be normal.There was no injury nor near injury at the area of entry.With the aid of trendelenburg and after the anterior abdominal wall anatomy was identified as well as the vasculature, two (2) puncture trocar sheaths were inserted under direct visualization and with the aid of the atraumatic grasper, the lower abdomen and pelvis were explored.There were multiple adhesions, especially in the left side and multiple cystic ovaries consistent what appeared to be the hemorrhagic cyst or endometriomas of the ovaries.The ureter was identified on both sides as well as the vasculature and bowel.On the left side, the infundibulopelvic was isolated and endocoagulated with harmonic scalpel with excellent results and excellent hemostasis.All of the adhesions were lysed with excellent results and excellent hemostasis without any injury to the bowel, vasculature, or bowel.The tissue was dissected off of the pelvic sidewall with excellent results and without any injury to the ureter.It should be noted that the ureter was visualized throughout the whole dissection and was well away from the area of dissection.There was excellent hemostasis throughout.The same procedure was carried on the other side identifying the infundibulopelvic ligament, identifying the ureter, vasculature, and bowel and with the aid of the harmonic scalpel, the infundibulopelvic ligament was endocoagulated, and then the mesovarium and mesosalpinx were endocoagulated with the ureter and vasculature well away from the area and visualized throughout the whole procedure.The area was well irrigated.There was complete and thorough hemostasis throughout.There was no injury to the bowel, ureter, or vasculature.The ovaries and tubes were removed through the larger of the two abdominal incisions with excellent results and excellent hemostasis.The pneumoperitoneum was released and there was no bleeding from any of the pedicles.The area was well irrigated.There was complete and thorough hemostasis throughout.At this point, the fascia on the larger of the three trocar incisions were closed with #0 monocryl using the carter-thomason instrument.The excess sheaths were removed.There was no active bleeding from the site.The pneumoperitoneum was released and the main sheath was removed.The incisions were closed with following the infraumbilical incision.The fascia was closed using #0 vicryl in a running interlocking type fashion.Skin was approximated using #4-0 monocryl and marcaine with epinephrine was infiltrated in the area for postoperative pain control.Steri-strips and dressing were applied.With in high lithotomy position with the area prepped and draped in sterile fashion, speculum was introduced into the vagina and the vaginal apex, which was prolapsed was grasped with two allis clamps.The anterior vagina was identified.The ureterovesical junction was identified and marked as well as the suburethral folds.The vagina was infiltrated with pitressin less than one pressor unit and incised in the midline.The bladder was dissected sharply and bluntly off the vaginal mucosa.The ischiorectal fossa was entered on either side.The ischial spines were identified as well as the sacrospinous ligament.Two sutures were placed to the sacrospinous ligament approximately one fingerbreadth medial to the ischial spines on either side.These sutures carried the uphold mesh.The uphold mesh was secured in the usual fashion with three anchoring sutures in the apex of the vagina of the vaginal vault and then to the anterior aspect of the vagina with excellent results and excellent hemostasis.The mesh was advanced in the usual fashion without overcorrection and without any banding formation.The mesh protective sheath was removed with excellent results and without overcorrection.The area was well irrigated.There was complete and thorough hemostasis.Floseal was used in the ischiorectal fossa as per the physician's' usual routine in all these cases.At this point, after irrigating the area well again, the vaginal mucosa was approximated using #2-0 vicryl in an interlocking type fashion with good hemostasis.The bladder was emptied.The mid urethra was identified.The vagina underlying the mid urethra was infiltrated with pitressin less than one pressor unit and incised.The tissue was dissected on either side to the level of the inferior pubic ramus, where the adductor longus muscle insertion to the inferior pubic ramus at the level of the clitoris.Using the halo needles from the obtryx system, the halo needles were passed with the vaginal finger guiding the needle, the needles were brought out through the vaginal incision without any injury and without going through the sulcus of the vagina.The mesh was then brought up on the ipsilateral side and secured underlying the mid urethra with excellent results and without overcorrection and without tension.Kelly clamp was used to assure there was no tension.The foley was removed.Cystoscopy was carried out.There was no injury to the urethra or the bladder.Indigo carmine had been given and blue efflux and normal amount was noted from both ureteral openings.After completing the cystoscopy, the foley catheter was reinserted.The area was well irrigated.There was complete and thorough hemostasis.The excess mesh was excised and the vulvar incisions were closed with #4-0 monocryl subcuticularly.Again, the vagina was well irrigated and the vagina was approximated using #2-0 vicryl in an interlocking type fashion with good hemostasis.At this point, a diamond shaped incision was made in the posterior vagina fourchette and the posterior vagina was infiltrated with pitressin less than one pressor unit and incised.The rectum was then dissected sharply and bluntly off the vaginal mucosa.Four anchoring sutures were placed to the levator ani muscles with excellent results and excellent hemostasis.A finger was in the rectum assuring that there was no suture into the rectum.After changing gloves and in the sterile fashion, the repliform mesh was secured above the apex of the vagina using #2-0 vicryl and then secured to the anchoring sutures with excellent results and excellent hemostasis.The mesh was trimmed and then the trailing end of the mesh was secured to the perineal body with #2-0 vicryl with interrupted sutures x3.The excess vagina was excised.The vagina was approximated in the midline using #2-0 vicryl in an interlocking type fashion to the introitus and then the perineoplasty was carried out with #2-0 vicryl with interrupted sutures and then completed with #2-0 vicryl in a subcuticular fashion with excellent results and excellent hemostasis.The instruments were removed.There was no active bleeding.The patient was returned to the supine position and taken to the post anesthesia recovery room in satisfactory condition with vital signs stable.Instrument, needle, and sponge counts were correct.On (b)(6) 2014, the patient was seen for a follow up check up 1.6 weeks post operation.Upon examination, the patient has well healed and suspended vaginal cuff.A small piece of mesh was removed without complications.The medication list of the patient was reviewed and reconciled with the patient.On (b)(6) 2014, the patient was seen and examined due to complaints of painful intercourse and a feeling of mesh material.Upon examination, it was noted that there were three small threads of mesh.All three were removed.Otherwise normal examination.The medication list of the patient was reviewed and reconciled with the patient.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2014, first clinic visit date, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

• Brand Name: PFR KIT UPHOLD LITE 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: 15570011
• MDR Text Key: 301496917
• Report Number: 3005099803-2022-05853
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: M0068317170
• Device Catalogue Number: 831-717
• Device Lot Number: ML00001327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 80 KG