MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y-MESH; MESH, SURGICAL, SYNTHETIC

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

Patient Problem Insufficient Information (4580)

Event Date 05/27/2019

Event Type  Injury  

Event Description

Note: this report pertains to one of two devices used for same patient.Refer to manufacturer report # 3005099803-2022-05756 for the associated device information.It was reported to boston scientific corporation that an uphold vaginal support system was used during an anterior uphold vaginal mesh repair, post repair, tension-free vaginal tape (tvt), and cystoscopy procedures performed on (b)(6) 2013 to treat a patient with stage 3 cystocele and rectocele with vault about one (1) cm above the hymen with traction, loss of pubo-urethral ligament support with bladder neck rotation and descent, and stress incontinence.The procedure was carried out normally.On (b)(6) 2019, the patient had recurrent stage two (2) traction cystocele, recto-enterocele, stage one (1) vault prolapse and recto-sigmoid and bladder adhesions to vault.The patient underwent an anterior repair, lap mesh sacro-colpopexy, pelvic adhesiolysis, cystoscopy and insert of surgical-pelvic organ pessary (s-pop) device procedures using an upsylon y-mesh.During the procedure, the patient was prepped and draped as per routine.The patient was placed in a low lithotomy position in allen stirrups and an indwelling catheter was inserted.Two grams of intravenous cephazolin plus 500 mg flagyl was administered to the patient prior to the start of the procedure.Thromboembolism-deterrent (ted) stockings plus semicircular canal dehiscence (sccd's) were used by the patient.An anterior repair procedure was started below the prior uphold lite mesh repair.A midline incision from the transverse sulcus to about two (2) centimeters below the vault was made.The bladder was reflected with sharp and blunt dissection.The fascia was then repaired with interrupted #2-0 pds upper transverse and both lateral sulci.The excess epithelium was trimmed and closed with a running, locking #2-0 vicryl rapide.A four port laparoscopy along 12 mm umbilical, 5 mm lif, 5 mm rif and 5(7) mm airseal port left flank site was performed.Minishear scissors was used for mobilization of the recto-sigmoid off vault.A #2-0 pds suture was then passed through the appendices epiploicae and was secured via left lateral external abdominal wall using endoclose device to retrieve the threads.Similar elevation of the bladder peritoneum to the suprapubic area as quite "floppy." then the peritoneum was opened at the vaginal vault with careful sharp and blunt dissection beneath the bladder for approximately two centimeters with vaginal probe in situ to the level of prior uphold mesh from prior repair.Quite vascular and serosal defect was noted over the base of the bladder and was oversewn with several #3-0 vicryl in an interrupted fashion with 100 ml saline in bladder.There was no attempt to dissect below this level.The posterior peritoneum was opened just below the vault and recto-vaginal space and was dissected down to the perineal body out to the levators.It was then confirmed on per vaginal (pv) with previously placed #2-0 vicryl suture and assisted with rectal probe.Then the peritoneum over the scral promontory was opened and dissected s/c tissues down to the anterior longitudinal ligament taking care to avoid the middle sacral vessels and the left common iliac vein.Dissection down the right sidewall medial to the ureter to the level of post peritoneal reflection.Cystoscopy was then performed and revealed a small hematoma beneath the bladder base with no perforation.Both vou's well lateral.The upsylon y-mesh was cut to length from prior measurements of 2 cm anterior and 7.5 cm posterior.#2-0 pds sutures was then used to secure the mesh initially to the anterior vault x 3 sutures (mesh not directly beneath the bladder serosal defect and small hematoma mentioned above).Then the posterior vault and posterior wall x 9 sutures.Then absorba tacs x 5 were placed with reliatac devices to secure the mesh to the anterior longitudinal ligament over sacral promontory avoiding tension.A #2-0 stratafix in a purse-string fashion was done for closure of the peritoneum over the vault up to the sacral promontory avoiding the right ureter.Additional 2 x #2-0 pds sutures in an interrupted fashion were used to ensure the mesh was completely covered at the vault.Excellent hemostasis was achieved after saline lavage.Approximately 80 ml of 0.2% naropin was instilled into pod at the end.Gas was then expelled.O maxon to the umbilical sheath was used and a #3-0 monocry; s/c plus dermabond were used to the skin wounds.A repeat cystoscopy was performed and the above mentioned hematoma just inside the posterior wall medial to vou's was noted as before.There were no perforation and good bilateral urine jets were seen.A medium sized surgical pelvic organ pessary (s-pop) device was inserted and secured with 2 x #2-0 vicryl sutures in an interrupted fashion just above the hymenal remnants.A 14-french gauge foley indwelling catheter was then re-inserted at the end.

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019, procedure date, as no event date was reported.The complainant was unable to provide the upn and lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).

• Brand Name: UPSYLON Y-MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach, spiddal; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15563174
• MDR Text Key: 301358266
• Report Number: 3005099803-2022-05757
• Device Sequence Number: 1
• Product Code: KOH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female