UNKNOWN
Report
- Report Number
- 2124215-2024-66648
- Event Type
- Injury
- Date Received
- October 29, 2024
- Date of Event
- January 1, 2011
- Report Date
- December 4, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- GEX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTED CONTENT PREVIOUSLY PROVIDED IN SECTIONS G1: MANUFACTURING SITE AND H8: USAGE OF DEVICE. GILFRICH, CHRISTIAN & MAY, MATTHIAS & FAHLENBRACH, CLAUS & GUNSTER, CHRISTIAN & JESCHKE, ELKE & POPKEN, GRALF & STOLZENBURG, JENS-UWE & WEIBBACH, LOTHAR & ZASTROW, CHRISTOPH & LEICHT, HANNA. (2020). SURGICAL RE-INTERVENTION RATES AFTER INVASIVE TREATMENT FOR LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC SYNDROME: A COMPARATIVE STUDY OF MORE THAN 43,000 PATIENTS WITH LONG-TERM FOLLOW-UP. JOURNAL OF UROLOGY. 205. 10.1097/JU.0000000000001463. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.
GILFRICH, CHRISTIAN & MAY, MATTHIAS & FAHLENBRACH, CLAUS & GUNSTER, CHRISTIAN & JESCHKE, ELKE & POPKEN, GRALF & STOLZENBURG, JENS-UWE & WEIBBACH, LOTHAR & ZASTROW, CHRISTOPH & LEICHT, HANNA. (2020). SURGICAL RE-INTERVENTION RATES AFTER INVASIVE TREATMENT FOR LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC SYNDROME: A COMPARATIVE STUDY OF MORE THAN 43,000 PATIENTS WITH LONG-TERM FOLLOW-UP. JOURNAL OF UROLOGY. 205. 10.1097/JU.0000000000001463.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF UROLOGY THAT A RETROSPECTIVE NON-RANDOMIZED STUDY WAS CONDUCTED USING THE CLAIMS DATA OF GERMANY'S LARGEST PROVIDER OF STATUTORY HEALTH INSURANCE (AOK). THE STUDY WAS CONDUCTED TO COMPARE THE REINTERVENTION RATES OF PATIENTS WHO HAD UNDERGONE 1 OF 4 DIFFERENT METHODS OF TREATMENT FOR BENIGN PROSTATIC OBSTRUCTION (BPO). THE PROCEDURES WERE CONDUCTED AT 516 DIFFERENT HOSPITALS IN GERMANY. ONE OF THE METHODS THAT WAS REVIEWED WAS PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURE. A TOTAL OF 3,050 PATIENTS UNDERWENT INITIAL PVP TREATMENT BETWEEN 2011 AND 2013. REVIEW OF THE DATA FOUND THAT 380 PATIENTS WHO HAD UNDERGONE PVP REQUIRED REINTERVENTION WITHIN 5 YEARS DUE TO EXPERIENCING LOWER URINARY TRACT SYMPTOMS (LUTS). ADDITIONALLY, 204 PATIENTS WHO HAD UNDERGONE PVP REQUIRED REINTERVENTION WITHIN 5 YEARS DUE TO EITHER URETHRAL STRICTURE (UR) OR BLADDER NECK CONTRACTURE (BNC). IT WAS NOTED THAT 704 OF THE PATIENTS WHO UNDERWENT PVP WERE NOT ABLE TO BE FOLLOWED FOR THE 5 YEAR FOLLOW-UP PERIOD DUE TO DEATH. THE CAUSE OR REASON FOR THE PATIENT'S DEATHS WAS NOT PROVIDED. THIS REPORT IS FOR THE ADVERSE EVENTS.
IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF UROLOGY THAT A RETROSPECTIVE NON-RANDOMIZED STUDY WAS CONDUCTED USING THE CLAIMS DATA OF GERMANY'S LARGEST PROVIDER OF STATUTORY HEALTH INSURANCE (AOK). THE STUDY WAS CONDUCTED TO COMPARE THE REINTERVENTION RATES OF PATIENTS WHO HAD UNDERGONE 1 OF 4 DIFFERENT METHODS OF TREATMENT FOR BENIGN PROSTATIC OBSTRUCTION (BPO). THE PROCEDURES WERE CONDUCTED AT 516 DIFFERENT HOSPITALS IN GERMANY. ONE OF THE METHODS THAT WAS REVIEWED WAS PHOTOSELECTIVE VAPORIZATION OF THE PROSTATE (PVP) PROCEDURE. A TOTAL OF 3,050 PATIENTS UNDERWENT INITIAL PVP TREATMENT BETWEEN 2011 AND 2013. REVIEW OF THE DATA FOUND THAT 380 PATIENTS WHO HAD UNDERGONE PVP REQUIRED REINTERVENTION WITHIN 5 YEARS DUE TO EXPERIENCING LOWER URINARY TRACT SYMPTOMS (LUTS). ADDITIONALLY, 204 PATIENTS WHO HAD UNDERGONE PVP REQUIRED REINTERVENTION WITHIN 5 YEARS DUE TO EITHER URETHRAL STRICTURE (UR) OR BLADDER NECK CONTRACTURE (BNC). IT WAS NOTED THAT 704 OF THE PATIENTS WHO UNDERWENT PVP WERE NOT ABLE TO BE FOLLOWED FOR THE 5 YEAR FOLLOW-UP PERIOD DUE TO DEATH. THE CAUSE OR REASON FOR THE PATIENT'S DEATHS WAS NOT PROVIDED. THIS REPORT IS FOR THE ADVERSE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1042948 | UNKNOWN | POWERED LASER SURGICAL INSTRUMENT | GEX | BOSTON SCIENTIFIC CORPORATION | UNK-P-GREENLIGHT FIBER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |