Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Irritation (1941); Pain (1994); Tissue Damage (2104); No Code Available (3191)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
The complete patient identifier is (b)(6).(b)(4).Study name: (b)(6).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
It was reported to boston scientific corporation that a pelvic floor reconstruction with uphold lite including apical vault suspension procedure performed on (b)(6) 2015.The patient also underwent a concomitant cystocele repair with native tissue.The procedure was completed without complications.According to the complainant, on (b)(6) 2019, the patient presented with symptomatic suture exposure in anterior vaginal wall of >1 cm in the area of suture line.The suture exposure was associated with pain only when provoked (during vaginal exam) and was reported to have led to a serious deterioration in health of the subject that resulted in medical or surgical intervention to prevent permanent impairment to body structure or body function.She was referred to a specialist and treated with estrace cream.The event has not yet resolved.The investigator assessed the event as moderate in severity, pelvic floor related, definitely related to the index procedure, definitely related to the study device, and definitely related to the delivery device.
 
Manufacturer Narrative
The complete patient identifier is (b)(6).Patient codes 1750 captures the reportable event of suture exposure.Study name: (b)(4) uphold lite.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.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
It was reported to boston scientific corporation that a pelvic floor reconstruction with uphold lite including apical vault suspension procedure performed on (b)(6) 2015.The patient also underwent a concomitant cystocele repair with native tissue.The procedure was completed without complications.According to the complainant, on (b)(6) 2019, the patient presented with symptomatic suture exposure in anterior vaginal wall of >1cm in the area of suture line.The suture exposure was associated with pain only when provoked (during vaginal exam) and was reported to have led to a serious deterioration in health of the subject that resulted in medical or surgical intervention to prevent permanent impairment to body structure or body function.She was referred to a specialist and treated with estrace cream.The event has not yet resolved.The investigator assessed the event as moderate in severity, pelvic floor related, definitely related to the index procedure, definitely related to the study device, and definitely related to the delivery device.Additional information received on november 25, 2019.The adverse event of suture exposure in vagina has been reassessed by the investigator as non-serious as it is unknown whether an intervention occurred for this patient.The patient's adverse event onset date was on (b)(6) 2019, which was also the date the patient exited the study.
 
Manufacturer Narrative
Additional information - block b7 updated.Block a1: the complete patient identifier is (b)(6) block g3: study name: u8090 uphold lite.Block h6: patient codes 1750 captures the reportable event of suture exposure.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.
 
Event Description
It was reported to boston scientific corporation that a pelvic floor reconstruction with uphold lite including apical vault suspension procedure performed on (b)(6), 2015.The patient also underwent a concomitant cystocele repair with native tissue.The procedure was completed without complications.According to the complainant, on (b)(6), 2019, the patient presented with symptomatic suture exposure in anterior vaginal wall of >1cm in the area of suture line.The suture exposure was associated with pain only when provoked (during vaginal exam) and was reported to have led to a serious deterioration in health of the subject that resulted in medical or surgical intervention to prevent permanent impairment to body structure or body function.She was referred to a specialist and treated with estrace cream.The event has not yet resolved.The investigator assessed the event as moderate in severity, pelvic floor related, definitely related to the index procedure, definitely related to the study device, and definitely related to the delivery device.***additional information received on (b)(6), 2019*** the adverse event of suture exposure in vagina has been reassessed by the investigator as non-serious as it is unknown whether an intervention occurred for this patient.The patient's adverse event onset date was on (b)(6), 2019, which was also the date the patient exited the study.
 
Manufacturer Narrative
Additional information: block b5 updated.Block a1: the complete patient identifier is (b)(6).Block g3: study name: (b)(4).Block h6: patient codes 1750 and 2104 capture the reportable events of mesh exposure and severe atrophy.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.
 
Event Description
It was reported to boston scientific corporation that a pelvic floor reconstruction with uphold lite including apical vault suspension procedure performed on (b)(6) 2015.The patient also underwent a concomitant cystocele repair with native tissue.The procedure was completed without complications.According to the complainant, on (b)(6) 2019, the patient presented with symptomatic suture exposure in anterior vaginal wall of 1cm in the area of suture line.The suture exposure was associated with pain only when provoked (during vaginal exam) and was reported to have led to a serious deterioration in health of the subject that resulted in medical or surgical intervention to prevent permanent impairment to body structure or body function.She was referred to a specialist and treated with estrace cream.The event has not yet resolved.The investigator assessed the event as moderate in severity, pelvic floor related, definitely related to the index procedure, definitely related to the study device, and definitely related to the delivery device.Additional information received on november 25, 2019.The adverse event of suture exposure in vagina has been reassessed by the investigator as non-serious as it is unknown whether an intervention occurred for this patient.The patient's adverse event onset date was on (b)(6) 2019, which was also the date the patient exited the study.Additional information received on july 23, 2020.The adverse event of suture exposure in vagina was determined to be a mesh exposure.The symptoms of this adverse event include "pain and irritation," "severe atrophy," and patient "unable to have relations.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UPHOLD LITE
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8966665
MDR Text Key156756669
Report Number3005099803-2019-04341
Device Sequence Number1
Product Code OTP
UDI-Device Identifier08714729839200
UDI-Public08714729839200
Combination Product (y/n)N
PMA/PMN Number
K122459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2017
Device Model NumberM0068318170
Device Catalogue Number831-817
Device Lot NumberML00002605
Was Device Available for Evaluation? No
Date Manufacturer Received07/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age63 YR
Patient Weight78
-
-