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

Model Number M0068504110

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2017, implant date, as no event date was reported.This event was reported by the patient's legal representation.The reported surgeon is: (b)(6).(b)(4).The complaint device 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 Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted into the patient during a procedure performed on (b)(6) 2017.As reported by the patient's attorney, the patient has experienced an unspecified injury.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6), 2020, the date the patient diagnosed with the symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient codes e2006, e1309, e2330, e2328, e1301, e1405, e2311, e1310 and e0127 capture the reportable events of erosion, urinary retention, pain, obstructive symptoms, dysuria, dyspareunia, discomfort, recurrent utis and delayed sensation.Impact code f1905 captures the reportable event of excision of exposed mesh.Block h10: 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 Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted into the patient during a tot placement with cystoscopy procedure performed on (b)(6)6, 2017 for the treatment of stress incontinence.On (b)(6), 2020, the patient presented for prolapse (vaginal bulge) and was diagnosed with worsening of overactive bladder, urinary retention, uds (urodynamic study) showed delayed sensation, vaginal mesh exposure, trouble urinating, recurrent utis (urinary tract infection), dyspareunia, frequency, sui (stress urinary incontinence), obstruction, and constipation.Possible excision of sling was discussed.An office visit on (b)(6), 2020 reported vaginal discharge and evidence of sling erosion in left side worth 2 cm and right side 0.5 cm lateral sulci.On (b)(6), 2020, the patient underwent mesh excision and tolerated the procedure well with no complications.On (b)(6), 2020, worsened sui (stress urinary incontinence) and uui (urgency urinary incontinence) and diagnosed with pelvic pain and spasms.Three months later post sling excision, there were no obstructive symptoms and uui was resolved; however, sui was increasing.Ongoing bladder/pelvic burning and discomfort.On (b)(6), 2021, patient was mostly bothered by sui, ongoing pelvic pain, pressure, discomfort that is worsening with urination and dyspareunia.The patient had to take interstim therapy again.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, the date the patient diagnosed with the symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) medical center.(b)(6).Block h6: patient codes e2006, e1309, e2330, e2328, e1301, e1405, e2311, e1310 and e0127 capture the reportable events of erosion, urinary retention, pain, obstructive symptoms, dysuria, dyspareunia, discomfort, recurrent utis and delayed sensation.Impact code f1905 captures the reportable event of excision of exposed mesh.Block h10: 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 Description

It was reported to boston scientific corporation that an obtryx ii system - curved device was implanted into the patient during a tot placement with cystoscopy procedure performed on (b)(6) 2017 for the treatment of stress incontinence.On (b)(6) 2020, the patient presented for prolapse vaginal bulge.Following the sling placement, the patient had worsening of overactive bladder and urinary retention that improved following interstim.Uds urodynamic study performed on an unknown date showed delayed sensation, no elevated voiding pressure, or detrusor overactivity, and no stress incontinence, but the patient reported symptoms of urgency, urge incontinence, stress incontinence, frequency, nocturia, obstructive symptoms with straining trouble urinating and feeling of incomplete emptying, recurrent urinary tract infections utis, and constipation.The patient also had vaginal mesh exposure that had not responded to estrace treatment started one month prior.She experienced dyspareunia.Possible excision of sling was discussed.An office visit on (b)(6) 2020 reported ongoing oab, straining to void, dyspareunia, and vaginal discharge.Exam revealed a 2cm sling erosion in the left lateral sulcus and a 0.5 cm erosion in the right lateral sulcus.Cystoscopy showed no evidence of intravesical or intraurethral mesh and no obvious etiology for the utis.On (b)(6) 2020, the patient underwent mesh excision and tolerated the procedure well with no complications.On (b)(6) 2020, worsened sui stress urinary incontinence and uui (urgency urinary incontinence) and diagnosed with pelvic pain and spasms.Interstim was turned off and pelvic floor physical therapy was recommended.On (b)(6) 2021, the patient reported no obstructive symptoms and uui was resolved; however, sui was increasing, and she had ongoing bladder/pelvic burning and discomfort.On (b)(6) 2021, patient was mostly bothered by sui but also reported ongoing pelvic pain, pressure, discomfort that is worsening with urination, and dyspareunia.She had been referred to pfpt but did not go.Her interstim had also been turned on.Exam revealed bilateral levator and obturator tenderness, left greater than right, levator more than obturator.The plan was for cystoscopy and macroplastique mpq injection.She was also referred again for pfpt.

• Brand Name: OBTRYX II SYSTEM - CURVED
• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12774902
• MDR Text Key: 280968730
• Report Number: 3005099803-2021-05750
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729839255
• UDI-Public: 08714729839255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2022

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: 04/04/2020
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: 0020492262
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 01/12/2022; 02/15/2022
• Supplement Dates FDA Received: 02/10/2022; 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 77 KG