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

Model Number	M0068318170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Purulent Discharge (1812); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Urinary Tract Infection (2120)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the information that the event started days after implantation on (b)(6) 2019.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 and explant surgeon is: (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an uphold lite vaginal support system device was implanted into the patient during a cystocele repair with uphold mesh, vesicourethropexy (with non-bsc sling), enterocele repair procedure performed on (b)(6) 2019 for the treatment of cystocele and stress incontinence.She underwent concomitant laparoscopic assisted hysterectomy, bilateral salpingectoophorectomy by another surgeon prior to the mesh placement part of the procedure.The patient tolerated the procedure satisfactorily and was discharged on post-operative day 1 tolerating a regular diet, ambulating / voiding without difficulty, and with pain controlled by po meds.The patient was seen for a post-operative follow-up visit on (b)(6) 2019.At that visit the patient reported she was still having a lot of pain but it was getting better each day.She was still having brown colored vaginal discharge and was changing her pad frequently due to the smell.Vaginal examination revealed infected uphold mesh with gaping of the anterior vaginal wall, exposed mesh with purulent bloody discharge.Culture and sensitivity were taken and it was decided that the mesh would be removed the following day.Culture showed gram-negative rods.Patient likely need to undergo a 7-10 days of iv antibiotic therapy.On (b)(6) 2019, the patient underwent a mesh removal.The chief complaint documented for the (b)(6) 2019 procedure was infected vaginal mesh repair and recurrent uti.Inspection of the vagina revealed that the site of the sling which was done for stress incontinence appears to be healthy no signs of infection at the bladder neck area.There is gaping of the anterior vaginal wall incision and the (uphold) mesh is exposed.The vaginal mucosa was edematous.Reportedly, necrotic tissue was also observed at the edges of the vaginal mucosa and was excised.The wound was irrigated thoroughly with multiple solution including saline, betadine, hydrogen peroxide, gentamicin and clorpactin.The radiation was done through a catheter inserted deep into the pelvic wound and each side until the irrigant fluid was clear for about half an hour.The mesh was then cut from the anchoring points in the anterior vaginal wall and was traced down inside the wound on each side to the sacrospinous ligament.The mesh was removed and sent for pathology examination.The surgeon was able to remove all the mesh from the right side and he could not see any remnant of it.Directing the attention to the left side, the surgeon was able to remove about 95% of the mesh but not completely removed in spite of multiple attempts with multiple instruments.Some remnants of the strands of the mesh was still attached deep into the wound.The surgeon spent about half an hour on the left side irrigating it and getting the rest as much as possible over the mesh.A small iv sterile tubing with a hole at the end was inserted deep in the wound and each side and was taped over the suprapubic area for irrigation.The vaginal wound was closed loosely using interrupted 2-0 vicryl sutures leaving a small gap in the middle left for any drainage and this is healed by secondary intention.The procedure ended and patient tolerated well.Blood loss was minimal.

• Brand Name: UPHOLD LITE
• Common Device Name: 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13006449
• Report Number: 3005099803-2021-06385
• Device Sequence Number: 16617761
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female