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

Model Number M0068502000

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

Patient Problems Hematoma (1884); Pain (1994); Perforation (2001); Blood Loss (2597)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Danish medicines agency (dkma) reference number: (b)(4); submitted to dkma (danish medicines agency) from the hospital.(b)(4).The complainant indicated that the device is implanted and will not 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 advantage sling was implanted during tension-free vaginal tape (tvt) sling procedure performed on (b)(6) 2018.According to the complainant, after 4 hours after the procedure, the patient experienced hematoma (approximately 9x7x5cm in size) behind the symphysis and it was drained in an operation the next day.Reportedly, there was no perioperative bleeding.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Danish medicines agency (dkma) reference number: 2018121577; submitted to dkma (danish medicines agency) from the hospital.The complainant indicated that the device is implanted and will not 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 advantage sling was implanted during tension-free vaginal tape (tvt) sling procedure performed on (b)(6) 2018.According to the complainant, the patient was in good condition when she was discharged from the hospital four hours after the procedure.However, she was then readmitted for five days ten hours after the procedure due to pain, and a 44x45x65mm hematoma was found behind the symphysis.The hematoma was reportedly due to the accidental puncture of a minor vein during the tvt procedure.Subsequently, the hematoma was drained abdominally in an operation on (b)(6) 2018 and the patient received prophylactic antibiotic for one week.The hematoma fully resolved after the drainage.Three months after the original procedure, the patient was called for a follow-up check-up.Reportedly, the patient was mistakenly booked for a follow-up phone call instead of a clinical control.Clinical consultation was then offered but the patient refused as she is reportedly very satisfied with the outcome and has no further complaints although the patient reported that she was not informed of the risk of hematoma as a result of the tvt procedure.In addition, it was reported that there was no preoperative bleeding.

Event Description

It was reported to boston scientific corporation that an advantage sling was implanted during tension-free vaginal tape (tvt) sling procedure performed on (b)(6) 2018.According to the complainant, the patient was discharged from the hospital 4 hours after the procedure, then she experienced hematoma (approximately 9x7x5cm in size) behind the symphysis and it was drained in an operation the next day.Reportedly, there was no preoperative bleeding.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

F10 and h6: problem code of 1884 for captures the reportable event of hematoma.G3: (b)(6) reference number: (b)(4); submitted to (b)(6) from the hospital.H6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.H10: the complainant indicated that the device is implanted and will not 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.H11: block b5 updated to report the correct event description.

• Brand Name: ADVANTAGE SYSTEM
• 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
• MDR Report Key: 8250371
• MDR Text Key: 133137473
• Report Number: 3005099803-2019-00077
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729470274
• UDI-Public: 08714729470274
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2021
• Device Model Number: M0068502000
• Device Catalogue Number: 850-200
• Device Lot Number: 0022187320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention