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

Model Number M0068505110

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Complaint, Ill-Defined (2331); No Code Available (3191); Dyspareunia (4505); Insufficient Information (4580)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.(b)(6) the revision surgery was performed by (b)(6) at (b)(6) hospital.(b)(4).The excised 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 obtryx ii system - halo device was implanted into the patient during a vaginal repair and obtryx sling placement procedure for stress urinary incontinence performed on (b)(6) 2016.As reported by the patient's attorney, the mesh eroded through the patient's anterior vaginal wall and was seen to extend laterally approximately 26mm on either side of the bladder neck.On (b)(6) 2016, the patient underwent mesh excision due to dyspareunia, pain, and mesh erosion.After the mesh excision, the patient still experiences occasional peroneal posterior coccygeal pain.It was also reported that the patient had "nerve/scar tissue/etc." boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

It was reported to boston scientific corporation that an obtryx ii system - halo device was implanted into the patient during a vaginal repair and obtryx sling placement procedure for stress urinary incontinence performed on (b)(6) 2016.As reported by the patient's attorney, the mesh eroded through the patient's anterior vaginal wall and was seen to extend laterally approximately 26mm on either side of the bladder neck.On (b)(6) 2016, the patient underwent mesh excision due to dyspareunia, pain, and mesh erosion.After the mesh excision, the patient still experiences occasional peroneal posterior coccygeal pain.It was also reported that the patient had "nerve/scar tissue/etc." **additional information received on november 28, 2022: on (b)(6) 2017, the patient underwent removal of obtryx sling and cystoscopy.During the surgery, it was discovered that the right arm of the sling was bunched up and tight.It was then removed in two pieces.The left arm was removed easily in one piece.Diagnoses at that time included mesh sling exposure across the right vaginal sulcus and pelvic and groin pain.On cystoscopy, there was no mesh noted in the bladder or urethra.

Manufacturer Narrative

Blocks b5 and h6 device codes have been updated based on the additional information received on november 28, 2022.Correction to block b3, section e and block g2.Block g2: company representative has been removed as the event was reported by the patient's legal representation.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2016 was chosen as a best estimate based on the date of the first revision surgery.Block e1: this complaint was received as litigation from a legal source in australia.The implant surgeon is: (b)(6).The revision surgery (december 2016) was performed by dr.(b)(6).The second revision surgery (september 2017) was performed by (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e1405 - dyspareunia, e2006 - mesh erosion, e1715 - scar tissue, e2401 - undescribed patient complications, e2330 - pain.Impact code f1905 captures the reportable event of mesh revision surgeries.

• Brand Name: OBTRYX II SYSTEM - HALO
• 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: 11138593
• MDR Text Key: 225732743
• Report Number: 3005099803-2020-06590
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729839279
• UDI-Public: 08714729837565
• 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: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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: 03/11/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: ML00003562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female