FDA Adverse Event Death Summary report: N

INTEGRITY RX CORONARY STENT SYSTEM

MDR report key: 1891200 · Received October 29, 2010

Report

Report Number: 2953200-2010-02095
Event Type: Death
Date Received: October 29, 2010
Date of Event: September 30, 2010
Report Date: September 30, 2010
Manufacturer: MEDTORNIC CARDIOVASCULAR GALWAY
Product Code: MAF
PMA / PMN Number: P030009
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION: RESULTS: PT CONDITION WAS GRAVE PRIOR TO THE PROCEDURE, DEATH. EVALUATION, CONCLUSION: PT CONDITION WAS GRAVE PRIOR TO THE PROCEDURE.

Description of Event or Problem · 1

A 2.5MM DIAMETER X 18MM LENGTH INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT WAS SUCCESSFULLY DEPLOYED IN TO A PT. THE TARGET LESION, LOCATED IN THE LEFT MAIN TO CIRCUMFLEX, EXHIBITED 99% STENOSIS. AFTER THIS, THE PHYSICIAN ATTEMPTED TO DEPLOY ONE OTHER INTEGRITY STENT THROUGH THE RELEVANT STENT; HOWEVER WHEN THE PHYSICIAN PULLED THE DEVICE BACK THE STENT DISLODGED IN THE VESSEL. THE PHYSICIAN INSERTED ANOTHER INTEGRITY STENT AND CRUSHED THE DISLODGED STENT INTO THE CIRCUMFLEX ARTERY WALL. THE PROCEDURE WAS COMPLETED AND THE PT WAS TRANSFERRED TO INTENSIVE CARE UNIT. IT WAS REPORTED THAT THE PT DIED THE NEXT DAY. THE PHYSICIAN COMMENTED THAT THE DEATH WAS NOT RELATED TO THE STENT DISLODGEMENT. THE PHYSICIAN ALSO CONFIRMED THAT THE PT PRESENTED TO CATH LAB IN SEVERE CONDITION AND ALTHOUGH SURVIVED THE PROCEDURE, HAD TO BE DEFIBRILLATED MORE THAN 20 TIMES. (MFR TEMPT # 2953200-2010-02094, 2953200-2010-02096).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTEGRITY RX CORONARY STENT SYSTEM		MAF	MEDTORNIC CARDIOVASCULAR GALWAY	NA	0004514098

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Death