FDA.reportPublic FDA data

MAUDE MDR 9834816

MDR report key
9834816
Report number
2135147-2020-00096
Event key
0
Event type
3
Date of event
2020-01-24
Date received
2020-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PAMELA YIP
Address
5050 NATHAN LANE N PLYMOUTH MN 55442 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMPLATZER SEPTAL OCCLUDERTRANSCATHETER SEPTAL OCCLUDERAGA MEDICAL CORPORATIONMLV9-ASD-0109-ASD-0107150613R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1601. R

Event Narratives#

N

Patient 1

THE REPORTED EVENT OF DEFORMATION UPON DEPLOYMENT OF THE 10MM OCCLUDER COULD NOT BE CONFIRMED. A SMALLER, 8MM, DEVICE WAS THEN SUCCESSFULLY IMPLANTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THE INSTRUCTIONS FOR USE ARTMT100116885 REV. A ALLOWS FOR SELECTION OF ONE SIZE LARGER THAN THE DIAMETER OF THE DEFECT, CONSISTENT WITH THE REPORTED EVENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT, COULD NOT BE CONCLUSIVELY DETERMINED.

D

Patient 1

ON (B)(6) 2020, A 10MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. DURING DEPLOYMENT A COBRA DEFORMATION WAS REPORTED. THE OCCLUDER WAS RESHEATHED AND REMOVED. A 8MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.