MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-10 for AHMED GLAUCOMA VALVE FP7 manufactured by New World Medical, Inc..
[187166630]
The issue reported describes a known complication of glaucoma drainage devices that relates to the surgeon leaving the tube too long in the anterior chamber or inserting the tube at an angle that leads to abutting the corneal endothelium, which can lead to loss of corneal endothelial cells. Leaving the tube too long or inserting at an angle that leads to touch with corneal endothelium are not in line with the ifu and would be an anticipated complication from not following the ifu. This is not a shortcoming of the device or an adverse event that is caused by improper functioning of the device.
Patient Sequence No: 1, Text Type: N, H10
[187166631]
Subject underwent right eye ahmed glaucoma implant surgery on (b)(6) 2019 as planned. During post operative day 1 visit on (b)(6) 2019, long tube in anterior chamber close to cornea was noted under slit-lamp examination with no other complications. Number of cell count was observed dropping gradually from month 1 to month 3 visit as compared to pre-operative visit, due to the length of the tube in anterior chamber. Thus the decision is to perform tube trimming in operating theatre as scheduled on (b)(6) 2020. Preoperative visit on (b)(6) 2019, the cell count number is 1715. Month 1 visit on (b)(6) 2019, the cell count number is 1385. Month 1. 5 visit on (b)(6) 2020, the cell count number is 1305. Month 3 visit on (b)(6) 2020 the cell count number is 1117.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000125279-2020-00009 |
| MDR Report Key | 9813731 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-03-13 |
| Date Added to Maude | 2020-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CRISTINA AVALOS |
| Manufacturer Street | 10763 EDISON COURT |
| Manufacturer City | RANCHO CUCAMONGA, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4664304 |
| Manufacturer G1 | NEW WORLD MEDICAL, INC. |
| Manufacturer Street | 10763 EDISON COURT |
| Manufacturer City | RANCHO CUCAMONGA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AHMED GLAUCOMA VALVE |
| Generic Name | GLAUCOMA SHUNT |
| Product Code | KYF |
| Date Received | 2020-03-10 |
| Model Number | FP7 |
| Catalog Number | FP7 |
| Lot Number | C0218 |
| Device Expiration Date | 2020-03-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEW WORLD MEDICAL, INC. |
| Manufacturer Address | 10763 EDISON COURT RANCHO CUCAMONGA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |