TVT EXACT RETROPUBIC SYSTEM
Report
- Report Number
- 2210968-2023-07661
- Event Type
- Injury
- Date Received
- October 12, 2023
- Date of Event
- September 7, 2023
- Manufacturer
- ETHICON INC.
- Product Code
- OTN
- UDI-DI
- 10705031062375
- PMA / PMN Number
- K132054
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE WHITE, FEMALE 78 KG BMI 29 NAME OF INDEX SURGICAL PROCEDURE? TVT EXAET KLEG10 THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? URINE STRESSINCONTINENCE WERE ANY CONCOMITANT PROCEDURES PERFORMED? NO WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? NONE (B)(6) 2023 OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? NO PLEASE PROVIDE THE SIZE AND LOCATION OF PERFORATION. LEFT SIDE IN THE BLADDER HOW WAS THE PERFORATION DIAGNOSED? CYSTOSKOPI PERIOPERATIV WERE THERE ANY OTHER COMPLICATIONS DURING THE INDEX PROCEDURE? NO WERE ANY ABNORMALITIES NOTED PRIOR, DURING, OR AFTER THE INDEX PROCEDURE? NO WERE THERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH DEVICE? NO PLEASE DESCRIBE ANY INTERVENTION REQUIRED TO REPAIR THE PERFORATION INCLUDING DATE AND RESULTS. TVT SLING WAS IN THE BLADDER, IT WAS REMOVED AND REARRANGED. 3 DAYS WITH CATHETER A DEMEUR 7/9-2023 WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? BLADDER PERFORATION IS A KNOWN COMPLICATION TO TVT SLING SYRGERY ( 2-5 % ) WHAT IS THE PATIENT´S CURRENT STATUS ? CURRED PRODUCT CODE AND LOT NUMBER? GYNECARE TVT LOG 13824954, LOT: 3944063 A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. UPDATED INFORMATION RECEIVED: ADVERSE EVENT TERM: PERFORATION OF THE BLADDER DURING THE TVT PROCEDURE UPDATED: IF EVENT IS SERIOUS AND DEVICE RELATED (UNLIKELY, POSSIBLE, PROBABLE, OR CAUSAL RELATIONSHIP), ACCORDING TO THE PROTOCOL AND INSTRUCTIONS FOR USE, IN THE OPINION OF THE INVESTIGATOR, IS THE ADVERSE EVENT EXPECTED/ANTICIPATED? YES / N/A.
(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE NAME OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? PLEASE PROVIDE THE SIZE AND LOCATION OF PERFORATION. HOW WAS THE PERFORATION DIAGNOSED? WERE THERE ANY OTHER COMPLICATIONS DURING THE INDEX PROCEDURE? WERE ANY ABNORMALITIES NOTED PRIOR, DURING, OR AFTER THE INDEX PROCEDURE? WERE THERE ANY DEFICIENCIES OR ANOMALIES NOTED WITH DEVICE? PLEASE DESCRIBE ANY INTERVENTION REQUIRED TO REPAIR THE PERFORATION INCLUDING DATE AND RESULTS. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? PRODUCT CODE AND LOT NUMBER? TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED GYNECOLOGICAL PROCEDURE ON (B)(6) 2023 AND MESH WAS IMPLANTED. DURING THE PROCEDURE, MODERATE PERFORATION OF THE BLADDER OCCURRED. THIS EVENT WAS REPORTED TO HAVE A CAUSAL RELATIONSHIP WITH THE STUDY DEVICE AND STUDY PROCEDURE. AS OF (B)(6) 2023, THE BLADDER PERFORATION HAS BEEN RECOVERED/RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1284727 | TVT EXACT RETROPUBIC SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC | OTN | ETHICON INC. | 3944063 | 10705031062375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Other |