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 Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Injury (2348)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.(b)(6).(b)(4).The complaint device 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

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that an obtryx ii system - halo and uphold lite were implanted into the patient during vault suspension, anterior repair and sacrospinous fixation procedures performed on (b)(6) 2016 to treat vaginal vault prolapse and stress incontinence.As reported by the patient's attorney, after the implantation, the patient has experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported that an obtryx ii system - halo and uphold lite were implanted into the patient during vault suspension, anterior repair and sacrospinous fixation procedures performed on (b)(6) 2016 to treat vaginal vault prolapse and stress incontinence.As reported by the patient's attorney, after the implantation, the patient has experienced an unknown injury.On (b)(6) 2017, the patient sought consult.The physician noted that the uphold lite mesh was partially embedded into the vaginal mucosa along the patient's left midline for approximately 25% of the middle part of the mesh.Both arms of the mesh were completely dissected free.The obtryx mesh was also noted to be embedded into the vaginal mucosa in the midline over a length of approximately 10 mm.The mesh was rolled into a tubular type structure for most of its length.The patient underwent a complete removal of the uphold lite mesh and the obtryx mesh that eroded into the patient's vaginal portion was removed.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient code 2348 captures the reportable event of unknown injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device 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.Block h11: blocks a1, a2, e1 (initial reporter title), e3 (occupation other), g2 and h7 have been corrected.Blocks b2, b5, h6 and h10 have been updated based on the additional information received on february 17, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The explant surgeon is: (b)(6).Block h6 patient code e2006 captures the reportable event of "mesh partially embedded into the vaginal mucosa." impact code f1905 captures the reportable event of the obtryx mesh that eroded into the patient's vaginal portion was removed.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2016, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Block h6: patient code 2348 captures the reportable event of unknown injury.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device 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.Block h11: blocks a1, a2, e1 (initial reporter title), e3 (occupation other), g2 and h7 have been corrected.Blocks b2, b5, h6 and h10 have been updated based on the additional information received on february 17, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The explant surgeon is: dr.(b)(6).Block h6 patient code e2006 captures the reportable event of "mesh partially embedded into the vaginal mucosa." impact code f1905 captures the reportable event of the obtryx mesh that eroded into the patient's vaginal portion was removed.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: blocks b5 and b7 have been corrected based on medical review on march 15, 2023.Block h10: this supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgments from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported that an obtryx ii system - halo and uphold lite were implanted into the patient during vault suspension, anterior repair and sacrospinous fixation procedures performed on (b)(6) 2016 to treat vaginal vault prolapse and stress incontinence.On (b)(6) 2016, during the implant procedures, a lot of scarring from the patient's previous procedures was noted.Moderate bleeding was noted following the uphold implant, and pressure was applied.As reported by the patient's attorney, after the implantation, the patient has experienced an unknown injury.Additional information received on february 17, 2023: on (b)(6) 2017, the patient sought consult.The physician noted that the uphold lite mesh was partially embedded into the vaginal mucosa along the patient's left midline for approximately 25% of the middle part of the mesh.Both arms of the mesh were completely dissected free.The obtryx mesh was also noted to be embedded into the vaginal mucosa in the midline over a length of approximately 10 mm.The mesh was rolled into a tubular type structure for most of its length.The patient underwent a complete removal of the uphold lite mesh and the obtryx mesh that eroded into the patient's vaginal portion was removed.

• 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: 11139326
• MDR Text Key: 225767788
• Report Number: 3005099803-2020-06642
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 04/24/2023

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: 08/26/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0000041220
• 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: 02/17/2023; 03/15/2023
• Supplement Dates FDA Received: 03/09/2023; 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female