FDA Adverse Event Death Summary report: N

SYNERGY¿

MDR report key: 7182201 · Received January 11, 2018

Report

Report Number: 2134265-2017-13194
Event Type: Death
Date Received: January 11, 2018
Date of Event: December 19, 2017
Report Date: December 19, 2017
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT, (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (AMI). VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RAMUS ARTERY WITH 100% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. AFTER PRE-DILATION, A 2.50 X 20 MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED, BUT SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING ADVANCING. THE STENT WAS DEPLOYED. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. NO DISSECTION OR PERFORATION WAS DETECTED. BUT THE PATIENT HAD CARDIOGENIC SHOCK. DESPITE CARDIOPULMONARY RESUSCITATION (CPR) WITH INCUBATION AND OTHER MEDICAL MANAGEMENT, THEY WERE NOT ABLE TO REVIVE THE PATIENT AND THE PATIENT DIED ON TABLE. NO AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS AMI AND CARDIOGENIC SHOCK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26687	SYNERGY¿	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493926220250	0020913876

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Death