MAUDE MDR 4117512

MDR report key
4117512
Report number
3010101669-2014-00004
Event key
0
Event type
3
Date of event
2014-08-21
Date received
2014-09-19
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
AMY WOLBECK
Address
1555 ADAMS DR MENLO PARK CA 94025 US
Phone
650-650-6506
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROPEL (MOMETASONE FUROATE IMPLANT 370 UG)DRUG ELUTING SINUS STENTINTERSECT ENTOWO700117001140520001R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-1901. R

Event Narratives#

D

Patient 1

ON (B)(6) 2014, A (B)(6) YEAR OLD MALE WITH A HISTORY OF CHRONIC SINUS DISEASE AND ASTHMA UNDERWENT ENDOSCOPIC SINUS SURGERY AND TWO PROPEL SINUS IMPLANTS WERE PLACED BILATERALLY IN THE ETHMOID SINUSES. THE PT WAS PLACED ON ANTIBIOTICS FOR 10 DAYS POST OPERATIVELY. ON DAY ONE POST-OP PACKING WAS REMOVED AND DAILY SALINE SINUS IRRIGATIONS WERE STARTED. ON (B)(6) 2014 (2 WEEKS POST-OP), THE PT COMPLAINED OF A SIGNIFICANT HEADACHE, DECREASE IN VISUAL ACUITY, AND OCULAR PAIN. DURING THE 2 WEEK POST-OPERATIVE VISIT, THE PHYSICIAN OBSERVED BOTH PERI-ORBITAL AND LAMINA PAPYRACEA INFLAMMATION; HE OPTED TO REMOVE THE IMPLANTS AND PLACED THE PT ON A ORAL STEROIDS. THE PT WAS REFERRED TO AN OPHTHALMOLOGIST, WHO DID NOT OBSERVE ANY OCULAR PATHOLOGY OR PRESCRIBE ANY ADDITIONAL MEDICATIONS. A CT SCAN WAS PERFORMED AND IT WAS REPORTED ON (B)(6) 2014, THAT THE SINUSES WERE CLEAR OF ANY SUBSEQUENT ISSUES. THE PT'S EYE SYMPTOMS HAD LESSENED, HOWEVER HE CONTINUED TO EXPERIENCE HEADACHES. THIS REPORT IS BASED ON INFO AVAILABLE TO THE COMPANY AT THE TIME THE REPORT WAS DUE FOR SUBMISSION AND MAY NOT REFLECT ALL INFO THAT MAY ULTIMATELY BECOME AVAILABLE THROUGH REQUESTS OR ANALYSIS.

N

Patient 1

BASED ON A REVIEW OF INTERNAL RECORDS, THE COMPANY WAS NOT ABLE TO ESTABLISH A FAILURE TO MEET SPECIFICATION. HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, THE COMPANY IS SUBMITTING THE REPORT BASED ON THE ALLEGATION OF INJURY AND THE NEED FOR MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE OR IMPAIRMENT.