FDA.reportPublic FDA data

MAUDE MDR 7468267

MDR report key
7468267
Report number
1220648-2018-00027
Event key
0
Event type
3
Date of event
2018-03-29
Date received
2018-04-27
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
MR. RALPH BARISANO
Address
22 CHERRY HILL DRIVE DANVERS 01923 US
Phone
978-978-9788
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPELLA RPRIGHT VENTRICULAR BYPASS (ASSIST) DEVICEABIOMED EUROPE GMBHOJEIMPELLA RP0043341250295Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-2701. R

Event Narratives#

N

Patient 1

THE IMPELLA RP AND PEEL-AWAY SHEATHS HAVE NOT YET BEEN RETURNED FOR EVALUATION. AT THIS TIME THERE IS NO DEFINITIVE INFORMATION INDICATING THAT THE INABILITY TO PLACE THE IMPELLA RP WAS THE RESULT OF ANY ISSUE WITH THE DEVICE. (B)(4).

D

Patient 1

THE COMPLAINANT REPORTED THAT (B)(6) YEAR OLD FEMALE PATIENT WAS IN A SLOWLY DECOMPENSATING CONDITION, AND WAS IN RIGHT HEAR FAILURE. A SWAN WAS PLACED IN THE PATIENT VIA THE RIGHT FEMORAL VEIN, BUT THERE WAS SOME INITIAL DIFFICULTY EXPERIENCED BY THE PHYSICIAN WHEN PLACING THE SWAN INTO THE LEFT PULMONARY ARTERY (LPA). THE PHYSICIAN THEN ATTEMPTED TO PLACE AN IMPELLA RP. WHEN ADVANCING THE PUMP OVER THE WIRE THE DEVICE WOULD NOT MAKE THE TURN INTO THE PULMONARY ARTERY (PA). AN 0.035 AMPLATZ WIRE WAS PLACED AS A BUDDY WIRE, BUT THIS WAS NOT SUCCESSFUL IN MAKING THE TURN INTO THE PA. DURING THE 35 MINUTE ATTEMPT TO PLACE THE IMPELLA RP, PATIENT BLEEDING OCCURRED FROM THE PEEL-AWAY SHEATH VALVE. TWO UNITS OF REPLACEMENT BLOOD WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THE PRESSURES DROPPING. THE SHEATH WAS EXCHANGED FOR ANOTHER RP PEEL-WAY SHEATH, BUT THE SAME ISSUE OCCURRED, AND THE PUMP WOULD NOT MAKE THE TURN INTO THE PA. IT WAS DECIDED TO ABORT THE IMPELLA RP PLACEMENT, AS A RESULT OF THE PATIENT'S CARDIAC ANATOMY. THE PHYSICIAN THEN PLACED A TANDEM HEART IN THE PATIENT VIA THE RIGHT INTERNAL JUGULAR.