MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502000

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

Patient Problems Erosion (1750); Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Rash (2033); Vomiting (2144); Numbness (2415); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 04/30/2015

Event Type  Injury  

Manufacturer Narrative

(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 advantage system device was implanted during an anterior and posterior vaginal repair, vaginal hysterectomy, sacrospinous hitch, tension-free vaginal tape insertion procedure performed on (b)(6) 2012 to treat stress incontinence.As reported by the patient's attorney, on (b)(6) 2015, the patient underwent a cystoscopy and examination under anesthesia (eua) procedure.During the procedure, the patient was given with general anesthesia and iv cephazolin.Reportedly, a sling erosion was observed in the lumen of the mid-urethra, positioned at 7 o'clock.On (b)(6) 2015, procedures like cystoscopy, excision of mid-urethral sling and urethral reconstruction were performed to the patient by a different surgeon and from a different healthcare facility.Following general anaesthesia, iv cephazolin and gentamicin, the patient was prepped and draped in the lithotomy procedure.The 22fr cystoscopy confirmed the eroded sling in the mid-urethra with at least 3 overlying calculi.Bladder was inspected with 30 and 70 degree telescopes and no mesh was seen in the bladder.A 16fr supracath was wired into the bladder with a 0.5%marcain, then an adrenaline infiltration of anterior vaginal wall was performed.The inverted u-shaped flap with a broad base was raised.One midurethral sling was identified (non-eroded) and its suburethral portion as well as two arms up to pubic rami were excised.Deeper eroded sling was identified.Vertical urethrotomy was made and the sling with calculi was removed.Urethra was closed vertically with interrupted 3/0 vicryl.On table leak test, it showed no fluid extravasation from repair.Flap of pubocervical fascia was raised as an interposing layer.It was sutured in place with 4/0 vicryl.Floseal was applied for venous ooze.Vagina was closed with 2/0 vicryl and vaginal pack was inserted.Post procedure, the patient woke up with screaming spasm pain from the bladder.Warm compression was applied and was given with 5mg of iv buscopan.Moreover, the spasm pain was better than before but still consistent.The patient also experienced numbness on the left thigh and left knee.On (b)(6) 2015, the patient was still experiencing spasm pain in the lower abdomen and couldn't move the leg medially.In addition, she had bladder spasm, with leaking small amount of urine and had thigh numbness but left toes movement sensation was present.The patient was given with ditropan to control her bladder spasms.The patient nauseated and vomited 200mls of bile fluids, so iv ondansetron and granisetron (prn) was given.The patient's face became red and she had a rash secondary to cephazolin.Moreover, the vaginal pack was removed, and there was a mild bruising observed at the anterior vaginal wall and a small amount of bleeding.On (b)(6) 2015, the nurse administered paracetamol to the patient for pain.Lastly, the patient and her family was taught about the post-operative care and the patient was prepared to be discharged.

• Brand Name: ADVANTAGE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 11138629
• MDR Text Key: 226030749
• Report Number: 3005099803-2020-06618
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 01/08/2021

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 Expiration Date: 09/30/2014
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: ML00000312
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR