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

Model Number M0068502000

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994); Urinary Retention (2119); Obstruction/Occlusion (2422); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 09/07/2011

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 was implanted on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; other pain: across pubis; painful intercourse; inability to have intercourse; difficulties with bowel motions; damage; psychiatric injury.Surgical interventions: on (b)(6) 2011 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: loosening of tape - was way too tight.On (b)(6) 2012 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: partial removal of tape - discovered endometriosis.On (b)(6) 2013 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: partial removal of tape.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: complete removal of mesh due to mesh erosion into vagina.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: deep botox.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: deep botox.Nonsurgical treatments: on (b)(6) 2016 the patient commenced pain medication: lyrica for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2015 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor and loosen and stretch.Treatment duration: 6 years on and off.On (b)(6) 2018 the patient commenced topical treatment (including oestrogen cream): vagifem and amitriptyline hcl estriol 2% 0.05% cream for the treatment of: lubrication and to treat erosion of vagina from tape.Treatment duration: 3 years.On (b)(6) 2016 the patient commenced pain medication: gabapentin for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: endone for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: targin for the treatment of: nerve pain and back pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: mobic for the treatment of: anti-inflammatory.Treatment duration: 5 years - on and off.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during an anterior and posterior repair + tvt sling procedure performed on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep - erosion / extrusion / protrusion of the mesh; back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; other pain: across pubis; painful intercourse; inability to have intercourse; difficulties with bowel motions; damage; psychiatric injury.Surgical interventions: on (b)(6) 2011 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: loosening of tape - was way too tight.On (b)(6) 2012 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: partial removal of tape - discovered endometriosis.On (b)(6) 2013 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: partial removal of tape.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: complete removal of mesh due to mesh erosion into vagina.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: deep botox.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: deep botox.Nonsurgical treatments: on (b)(6) 2016 the patient commenced pain medication: lyrica for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2015 the patient commenced physiotherapy treatment, including pelvic floor exercises or training, for the treatment of: pelvic floor and loosen and stretch.Treatment duration: 6 years on and off.On (b)(6) 2018 the patient commenced topical treatment, including oestrogen cream: vagifem and amitriptyline hcl estriole 2 percent 0.05 percent cream for the treatment of: lubrication and to treat erosion of vagina from tape.Treatment duration: 3 years.On (b)(6) 2016 the patient commenced pain medication: gabapentin for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: endone for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: targin for the treatment of: nerve pain and back pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: mobic for the treatment of: anti - inflammatory.Treatment duration: 5 years - on and off.Additional information received on january 5, 2023: on (b)(6) 2011, the patient was diagnosed with urinary retention and had to undergo posterior division of tape plus cystoscopy.On (b)(6) 2013, it was reported that the patient had urethral obstruction and chronic pelvic pain.She had sling removal, cystoscopy and laparoscopic division surgery.On (b)(6) 2019, the patient received pulsed radio frequency of pubic symphysis + pudendal nerve block right + dysport.Patient indicated the focus of pain trigger while awake.Focus was located on both sides of the symphysis at approximately 3cm from midline left and right asymmetry of the levator muscle.Increased bulk of obturator internus and puborectalis.Patient was admitted for pain control, requiring ketamine infusion and subcutaneous morphine for 48 hours.On (b)(6) 2019, patient had another revision surgery for mesh removal and pudendal nerve block.Dissection was more difficult on the left as the distal end portion of tape has migrated laterally.There were four separate pieces of mesh removed.

Manufacturer Narrative

Block a1: meshc-20210927-f371036c.Block b3 date of event: the exact event onset date is unknown.The provided event date of september 7, 2011 was chosen as a best estimate based on the date of first revision surgery.Block e1 this complaint was received as litigation from a legal source in australia.The device was implanted at (b)(6) hospital.Block h6: imdrf patient codes e2006, e2328, e1309, e2330, e1405 and e0206 capture the reportable events of erosion, urethral obstruction, urinary retention, chronic pelvic pain, dyspareunia and unspecified mental, emotional or behavioral problem.Imdrf impact codes f1905, f1901 and f1903 capture the reportable events of mesh excision, division of tape, pudendal nerve block and complete mesh removal.Block 11: blocks d6b explant date and h6 impact codes have been corrected.

Event Description

It was reported to boston scientific corporation that an advantage system device was implanted into the patient during an anterior and posterior repair + tvt sling procedure performed on (b)(6) 2011.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; groin pain; perineum pain; anal pain; rectal pain; other pain: across pubis; painful intercourse; inability to have intercourse; difficulties with bowel motions; damage; psychiatric injury surgical interventions: on (b)(6) 2011 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: loosening of tape - was way too tight.On (b)(6) 2012 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: partial removal of tape - discovered endometriosis.On (b)(6) 2013 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: partial removal of tape.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: complete removal of mesh due to mesh erosion into vagina.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: deep botox.On (b)(6) 2019 the patient underwent further surgery regarding the advantage implant under general anesthesia for the following purpose: deep botox.Nonsurgical treatments: on (b)(6) 2016 the patient commenced pain medication: lyrica for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2015 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: pelvic floor and loosen and stretch.Treatment duration: 6 years on and off.On (b)(6) 2018 the patient commenced topical treatment (including oestrogen cream): vagifem and amitriptyline hcl estriole 2% 0.05% cream for the treatment of: lubrication and to treat erosion of vagina from tape.Treatment duration: 3 years.On (b)(6) 2016 the patient commenced pain medication: gabapentin for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: endone for the treatment of: nerve pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: targin for the treatment of: nerve pain and back pain.Treatment duration: 5 years - on and off.On (b)(6) 2016 the patient commenced pain medication: mobic for the treatment of: anti-inflammatory.Treatment duration: 5 years - on and off.---additional information received on january 5, 2023--- on (b)(6) 2011, the patient was diagnosed with urinary retention and had to undergo posterior division of tape plus cystoscopy.On (b)(6) 2013, it was reported that the patient had urethral obstruction and chronic pelvic pain.She had sling removal, cystoscopy and laparoscopic division surgery.On (b)(6) 2019, the patient received pulsed radio frequency of pubic symphysis + pudendal nerve block right + dysport.Patient indicated the focus of pain trigger while awake.Focus was located on both sides of the symphysis at approximately 3cm from midline left and right asymmetry of the levator muscle.Increased bulk of obturator internus and puborectalis.Patient was admitted for pain control, requiring ketamine infusion and subcutaneous morphine for 48 hours.On (b)(6) 2019, patient had another revision surgery for mesh removal and pudendal nerve block.Dissection was more difficult on the left as the distal end portion of tape has migrated laterally.There were four separate pieces of mesh removed.

Manufacturer Narrative

Blocks b5, section d suspect medical device and h6 patient codes and impact codes have been updated based on the additional information received on january 5, 2023.Block a1: (b)(6).Block b3 date of event: the exact event onset date is unknown.The provided event date of september 7, 2011 was chosen as a best estimate based on the date of first revision surgery.Block e1 this complaint was received as litigation from a legal source in australia.The device was implanted at (b)(6) private hospital.Block h6: imdrf patient codes e2006, e2328, e1309, e2330, e1405 and e0206 capture the reportable events of erosion, urethral obstruction, urinary retention, chronic pelvic pain, dyspareunia and unspecified mental, emotional or behavioral problem.Imdrf impact codes f1905 and f1901 capture the reportable events of mesh excision, division of tape, and pudendal nerve block.

• 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: 12930733
• MDR Text Key: 286928038
• Report Number: 3005099803-2021-07372
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020110
• 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,Followup,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• 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: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 1ML1021601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2011
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG