FDA Adverse Event Death Summary report: N

CARDIVA MEDICAL VVASCADE 6/7F VCS

MDR report key: 7630137 · Received June 22, 2018

Report

Report Number: 3004182619-2018-00015
Event Type: Death
Date Received: June 22, 2018
Date of Event: May 22, 2018
Report Date: June 22, 2018
Manufacturer: CARDIVA MEDICAL, INC.
Product Code: MGB
PMA / PMN Number: P120016
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCLUSION: THE REPORTED EVENT WAS NOT RELATED TO DEVICE MALFUNCTION. PER THE INITIAL REPORT THIS COULD HAVE BEEN THE RESULT OF THE HIGH STICK, BUT THIS COULD NOT BE DETERMINED. COMPLICATIONS SUCH AS RETROPERITONEAL BLEEDING ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO ENDOVASCULAR PROCEDURES OR VASCULAR CLOSURE.

Description of Event or Problem · 1

PROCEDURE WAS AN INTERVENTIONAL CASE TO REPAIR A LAD WITH A STENT. THE VASCADE DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED, TEMPORARY HEMOSTASIS WAS ACHIEVED, AND THE SHEATH WAS REMOVED. THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE RETRACTED TO EXPOSE THE COLLAGEN. THE COLLAGEN WAS STRIPPED OFF THE WIRE, THE DISC WAS DE-DEPLOYED AND THE DEVICE WAS REMOVED. WHEN THE PATIENT WAS MOVING TO RECOVERY, THE PATIENT WAS NOTED WITH ST ELEVATIONS AND RETURNED TO PROCEDURE TABLE. IT WAS DETERMINED THAT THE PATIENT HAD A RETROPERITONEAL BLEED. PATIENT RECEIVED MULTIPLE UNITS OF BLOOD, BUT CODED AND THE PATIENT EXPIRED. A REVIEW OF THE ANGIOGRAM WAS PERFORMED WHICH SHOWED THE ACCESS SITE WAS ABOVE THE PELVIC RIM, WHICH WOULD INDICATE A HIGH STICK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
471013	CARDIVA MEDICAL VVASCADE 6/7F VCS	VASCADE 6/7F	MGB	CARDIVA MEDICAL, INC.	700-580I	G580I180329A

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Death