UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT
Report
- Report Number
- 3012236936-2023-01513
- Event Type
- Injury
- Date Received
- June 30, 2023
- Report Date
- July 12, 2024
- Manufacturer
- AMO MANUFACTURING NETHERLANDS
- Product Code
- KYF
- PMA / PMN Number
- K955455
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION: UPON FURTHER REVIEW ON JUN 14, 2024, IT WAS NOTED THAT SECTION D4 MODEL NUMBER WAS SUBMITTED AS 101-350 ON THE INITIAL MDR, BUT SHOULD BE UNKNOWN. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELD HAS BEEN UPDATED ACCORDINGLY: SECTION D4: MODEL NUMBER: UNKNOWN ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
SECTION A2: MEAN AGE 62.2 ± 13.5. SECTION A3: 13 FEMALE (55%), 11 MALE (45%). SECTION A4: INFORMATION UNKNOWN/NOT PROVIDED. SECTION A5: CAUCASIAN 17 (70.8%), AFRO-CARIBBEAN 5 (20.8%), ASIAN 2 (8.3%). SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN MARCH 2014 TO JULY 2018. SECTION D4: CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED SECTION D6B - EXPLANT DATE: N/A, DEVICE REMAINS IMPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: STRINGA F, CHEN R, AGRAWAL P. ONE-YEAR OUTCOMES FOLLOWING INTERNAL LIGATION SUTURE REMOVAL IN 350 MM2 BAERVELDT TUBE IMPLANT SURGERY. J CURR GLAUCOMA PRACT 2022;16(1):20¿23. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: ONE-YEAR OUTCOMES FOLLOWING INTERNAL LIGATION SUTURE REMOVAL IN 350 MM2 BAERVELDT TUBE IMPLANT SURGERY A PROSPECTIVE, CONSECUTIVE, NON-COMPARATIVE CASE SERIES WAS DONE TO EVALUATE THE OUTCOME AND THE SAFETY PROFILE OF INTERNAL LIGATION SUTURE REMOVAL AFTER BVT SURGERY FOR REFRACTORY GLAUCOMA. THE SERIES INCLUDED 24 CONSECUTIVE GLAUCOMA PATIENTS (N=24 EYES) IN WHOM A 350 MM2 BVT (ABBOTT MEDICAL OPTICS, SANTA ANA, CA) HAD BEEN IMPLANTED OVER A PERIOD OF 4 YEARS. ALL 350 MM2 BVTS WERE INTERNALLY LIGATED WITH A 3-0 SUPRAMID (S. JACKSON INC., ALEXANDRIA, VA, USA) SUTURE AS WELL AS EXTERNALLY LIGATED WITH A 10-0 NYLON SUTURE, WHICH WAS THEN SUTURE LYSED AFTER 3¿4 WEEKS IF THE IOP WAS SUBOPTIMAL. THE SUPRAMID INTERNAL LIGATION SUTURE WAS THEN FULLY REMOVED AFTER A MINIMUM OF 4 WEEKS FOR FURTHER IOP LOWERING IF CLINICALLY INDICATED. COMPLICATIONS INCLUDED: HYPOTONY (N=2), NOTED AT DAY ONE POSTOPERATIVELY; AND PERSISTED FOR 2 WEEKS (N=1) AND 3 WEEKS (N=1). BOTH WERE MANAGED CONSERVATIVELY THROUGH OBSERVATION AND MEDICAL MANAGEMENT. VITREOUS OCCLUSION OF THE TUBE OR VITREOUS IN THE ANTERIOR CHAMBER (N=1) CAUSING AN INTRAOCULAR PRESSURE (IOP) SPIKE OF 55 MM HG, UNDERWENT AN ANTERIOR VITRECTOMY AT 1 WEEK FOLLOWING SUPRAMID REMOVAL; THE IOP SETTLED WITH GLAUCOMA MEDICATIONS AT 12 MONTHS. THERE WERE NO FURTHER INTERVENTIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1255174 | UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT | IMPLANT, EYE VALVE | KYF | AMO MANUFACTURING NETHERLANDS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |