UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT
Report
- Report Number
- 3012236936-2024-000279
- Event Type
- Injury
- Date Received
- October 16, 2024
- Report Date
- October 16, 2024
- Manufacturer
- AMO MANUFACTURING NETHERLANDS
- Product Code
- KYF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SECTION A3B, A4, A5 AND A6: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3 - DATE OF EVENT: DATE NOT PROVIDED. SECTION D4 - MODEL NUMBER: UNKNOWN/ NOT PROVIDED. SECTION D4 - CATALOG NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/NOT PROVIDED SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/NOT PROVIDED. SECTION D6B - EXPLANT DATE: N/A AS DEVICE REMAINS IMPLANTED. SECTION G4 - PMA/510(K) NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN. AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: KAWAMURA, H., IKEDA, H., NUMA, S., MORI, Y., MIYAKE, M., SUDA, K., KAMEDA, T., & TSUJIKAWA, A. (2024, SEPTEMBER 22). CASE REPORT OF LOW INTRAOCULAR PRESSURE DUE TO TUBE RUPTURE RESULTING IN EXCESSIVE FILTERING AFTER LONG TUBE SHUNT SURGERY. IN T. YAMASHITA (CHAIR), 35TH ANNUAL MEETING OF THE JAPANESE GLAUCOMA SOCIETY [GENERAL PRESENTATION]. ACRIE HIMEJI, HIMEJI, JAPAN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: A CASE OF HYPOTONY DUE TO OVERFILTRATION FROM DISRUPTED TUBE AFTER LONG TUBE SHUNT SURGERY THE 35TH MEETING OF JAPAN GLAUCOMA SOCIETY. CASE REPORT (B)(4). INTRODUCTION: WE REPORT A CASE OF A PATIENT WHO DEVELOPED EXCESSIVE FILTRATION DUE TO TUBE RUPTURE AFTER A LONG-TUBE SHUNT SURGERY. THE RUPTURE WAS TREATED WITH REOPERATION BY SUTURING BOTH ENDS OF THE TUBE, LEADING TO SUCCESSFUL INTRAOCULAR PRESSURE (IOP) CONTROL. CASE REPORT A 79-YEAR-OLD WOMAN WITH PRIMARY OPEN-ANGLE GLAUCOMA UNDERWENT BILATERAL TRABECULECTOMY AT THE AGE OF 55 AND BILATERAL CATARACT SURGERY AT THE AGE OF 73. AT THE AGE OF 75, AFTER UNDERGOING VITRECTOMY AND SCLERAL FIXATION OF THE INTRAOCULAR LENS FOR LEFT INTRAOCULAR LENS DISLOCATION, HER LEFT INTRAOCULAR PRESSURE BECAME UNCONTROLLABLE, AND SHE WAS REFERRED TO OUR DEPARTMENT. AT HER INITIAL VISIT, WHILE USING FIVE TYPES OF IOP-LOWERING EYE DROPS AND TAKING A CARBONIC ANHYDRASE INHIBITOR ORALLY, HER IOP WAS 10 MMHG IN THE RIGHT EYE AND 14 MMHG IN THE LEFT EYE. BOTH EYES HAD ALREADY LOST CENTRAL VISUAL FIELDS. A BAERVELDT GLAUCOMA IMPLANT WAS PLACED IN HER LEFT EYE, WITH THE TUBE TIP INSERTED INTO THE VITREOUS CAVITY. FROM THE DAY AFTER THE SURGERY, SHE DEVELOPED HYPOTONY WITH IOP AROUND 1¿2 MMHG AND SEVERE CHOROIDAL DETACHMENT, WITH NO SIGNS OF IMPROVEMENT. A REOPERATION WAS PERFORMED ON DAY 7. UPON INSPECTION, THE TUBE WAS FOUND TO BE RUPTURED NEAR THE LIGATION SITE WITH ABSORBABLE SUTURES. BOTH ENDS OF THE TUBE WERE SUTURED TOGETHER, AND A 3-0 NYLON STENT WAS INSERTED INTO THE TUBE. ON POSTOPERATIVE DAY 30, THE STENT WAS REMOVED, AND THE IOP IN THE LEFT EYE STABILIZED AROUND 10 MMHG WITH THE USE OF ONE EYE DROP. IN CASES WHERE SEVERE POSTOPERATIVE HYPOTONY PERSISTS, THE POSSIBILITY OF TUBE RUPTURE SHOULD BE CONSIDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1286880 | UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT | IMPLANT, EYE VALVE | KYF | AMO MANUFACTURING NETHERLANDS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Required Intervention |