BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number M0068318170 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Hemorrhage/Bleeding (1888); 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 second 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.
|
|
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, d6b, 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 f1903 captures the reportable event of the complete removal of the uphold lite mesh.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.
|
|
Event Description
|
Note: this manufacturer report pertains to the second 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 november 1, 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, d6b, 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 f1903 captures the reportable event of the complete removal of the uphold lite mesh.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, b7, h6 and h10 have been corrected based on the medical review received on march 15, 2023.Block h6: patient code e2006 captures the reportable event of "mesh partially embedded into the vaginal mucosa." patient code e0506 captures the reportable event of "bleeding." impact code f1903 captures the reportable event of the complete removal of the uphold lite mesh.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.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 second 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.
|
|
Search Alerts/Recalls
|
|
|