FDA Adverse Event Death Summary report: N

BERLIN HEART EXCOR PEDIATRIC VAD

MDR report key: 7685269 · Received July 13, 2018

Report

Report Number: 3004582654-2018-00036
Event Type: Death
Date Received: July 13, 2018
Date of Event: June 13, 2018
Report Date: July 13, 2018
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
PMA / PMN Number: P160035
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). THE PATIENT WAS IMPLANTED FROM (B)(6) 2018. BASED ON THE INFORMATION PROVIDED TO BERLIN HEART (B)(4) BY THE SITE AND DISTRIBUTOR, THERE IS NO INCIDENCE OF A MALFUNCTION OF THE EXCOR VAD SYSTEM, WHICH LED TO A THROMBUS FORMATION. BERLIN HEART (B)(4) RECEIVED BACK ONLY THE BLOOD PUMP USED IN EXCOR VAD SYSTEM, SERIAL (B)(4), AND VISUAL INSPECTION FOUND THROMBUS IN THE BLOOD CHAMBER. THE PUMP WAS DISMOUNTED AND ANALYZED IN DETAIL. NO DEFECT WAS DETECTED. ALL THREE MEMBRANE LAYERS ARE INTACT AND SHOW NO ANOMALY. ADVERSE EVENT TERM: ISCHEMIC CVA.

Description of Event or Problem · 0

ON (B)(6) 2018, THE DISTRIBUTOR CONTACTED BERLIN HEART (B)(4) VIA EMAIL TO REPORT A PATIENT SUPPORTED IN LVAD CONFIGURATION OF THE EXCOR BLOOD PUMP DEVELOPED FIBRIN IN THE INFLOW CANNULA. ANTICOAGULATION WAS WITHIN TARGET RANGE ACCORDING TO THE SITE. DESPITE ANTICOAGULATION TREATMENT, THE PATIENT EXPIRED ON (B)(6) 2018 AFTER EXPERIENCING AN ISCHEMIC CVA AND MULTIPLE STROKES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
528644	BERLIN HEART EXCOR PEDIATRIC VAD	VENTRICULAR ASSIST DEVICE	DSQ	BERLIN HEART GMBH

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 YR		Death