FDA Adverse Event Death Summary report: N

SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

MDR report key: 15200286 · Received August 10, 2022

Report

Report Number: 3015053858-2022-00050
Event Type: Death
Date Received: August 10, 2022
Report Date: July 21, 2022
Manufacturer: SHOCKWAVE MEDICAL, INC.
Product Code: QMG
PMA / PMN Number: P200039
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE REFERENCED IN THIS PUBLICATION WAS NOT RETURNED THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, ONE PATIENT DURING THE STUDY EXPERIENCED STROKE WHICH RESULTED IN DEATH. DUE TO INSUFFICIENT INFORMATION/ DETAILS REGARDING THE EVENT, THE CAUSE IS NOT ESTABLISHED - INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED DEATH WITHIN THE PUBLICATION. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED.

Description of Event or Problem · 0

FROM PUBLICATION ITSELF (IRISH JOURNAL OF MEDICAL SCIENCE (1971 -). HTTPS://DOI.ORG/10.1007/S11845-022-03077-9): A RETROSPECTIVE SINGLE-CENTER STUDY WAS CONDUCTED OF PATIENTS TREATED WITH CORONARY IVL BETWEEN JANUARY AND OCTOBER 2020. A TOTAL OF 62 SHOCKWAVE¿ BALLOONS WERE USED IN 47 PATIENTS. PROCEDURAL OUTCOMES (REFERENCE TABLE 3 OF PUBLICATION): WITHIN THE PUBLICATION, IT WAS NOTED THAT ONE DEATH WAS CAUSED BY STROKE DURING THE STUDY AT THE ST. JAMES HOSPITAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
399387	SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER	NTRAVASCULAR LITHOTRIPSY (IVL) CATHETER	QMG	SHOCKWAVE MEDICAL, INC.	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Death