FDA Adverse Event Injury Summary report: N

ISTENT TRABECULAR MICRO-BYPASS

MDR report key: 3872128 · Received April 17, 2014

Report

Report Number: 2032546-2014-00011
Event Type: Injury
Date Received: April 17, 2014
Date of Event: March 19, 2014
Report Date: March 19, 2014
Manufacturer: GLAUKOS CORPORATION
Product Code: OGO
PMA / PMN Number: P080030
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE STENT REMAINS IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATED TO THE REPORTED EVENT. ENDOPHTHALMITIS IS LISTED IN THE DEVICE LABELING AS A KNOWN INHERENT RISK OF CATARACT AND GLAUCOMA STENT SURGERY. MFR REFERENCE #: (B)(4). SUBMITTED TO FDA ON 04/17/2014.

Description of Event or Problem · 1

THE SURGEON REPORTED PERFORMING UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE ISTENT IN THE LEFT EYE. AT ONE DAY POSTOPERATIVE VISIT, THE PATIENT PRESENTED WITH SUSPECTED ENDOPHTHALMITIS IN THE OPERATIVE EYE. A CULTURE WAS OBTAINED AND THE PATIENT WAS TREATED WITH AN INTRAVITREAL INJECTION OF VANCOMYCIN/CEFTAZIDIME AND REFERRED TO A RETINAL SPECIALIST. THE PATIENT WAS ALSO PRESCRIBED DUREZOL, BESIVANCE, PROLENSA, AND LOTEMAX. THE CULTURE REPORT CAME BACK NEGATIVE/NO GROWTH IDENTIFIED. AT THE MOST RECENT VISIT, THE PATIENT STATUS WAS REPORTED AS IMPROVING AND RESPONDING TO TREATMENT, WITH INFLAMMATION GREATLY REDUCED AND THE PROGNOSIS IS GOOD. THIS EVENT IS BEING REPORTED ON THE BASIS OF ETIOLOGY UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
235050	ISTENT TRABECULAR MICRO-BYPASS	INTRAOCULAR PRESSURE LOWERING IMPLAN	OGO	GLAUKOS CORPORATION	GTS100L	102581

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR		Required Intervention	OCULAR INSTRUMENTS, BELLEVUE WA\| OCULAR TRABECULAR BYPASS GONIOPRISM,