RESOLUTE INTEGRITY RX

MDR report key: 3070008 · Received April 22, 2013

Report

Report Number: 9612164-2013-00447
Event Type: Death
Date Received: April 22, 2013
Date of Event: November 11, 2013
Report Date: August 8, 2014
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P110013
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (DEATH). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH). (B)(4).

Additional Manufacturer Narrative · 1

EVALUATION RESULTS AND CONCLUSION: (MYOCARDIAL INFARCTION). (B)(4).

Description of Event or Problem · 1

CLINICAL EVENTS COMMITTEE HAVE ADJUDICATED THAT THE REPORTED MI OCCURRED ONE DAY PRIOR TO THAT PREVIOUSLY REPORTED AND WAS AN ARC MI.

Description of Event or Problem · 1

APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED PNEUMONIA WITH AN OUTCOME OF DEATH.

Description of Event or Problem · 1

DATE OF DEATH IS CONFIRMED AS THE (B)(6) 2013. CEC HAS INDICATED PATIENT DEATH WAS NON-CARDIAC DUE TO PNEUMONIA WITH CAD AND PULMONARY FIBROSIS AS CONTRIBUTING FACTORS.

Description of Event or Problem · 1

DURING INDEX PROCEDURE THE PATIENT HAD TWO RESOLUTE INTEGRITY DRUG-ELUTING STENTS IMPLANTED, ONE IN THE LAD AND ONE IN THE LCX. ONE DAY POST INDEX PROCEDURE, A PERI-PROCEDURAL MI WAS REPORTED WITH A RISE IN CKMB. THE PATIENT RECOVERED WITHOUT TREATMENT. INVESTIGATOR DID NOT INDICATE WHETHER THE REPORTED EVENT WAS RELATED TO THE STUDY DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
172422	RESOLUTE INTEGRITY RX	STENT, CORONARY, DRUG-ELUTING	NIQ	MEDTRONIC IRELAND		0006640043

Patients

Seq	Age	Sex	Outcome	Treatment
1	00074 YR		Death\| H	CLOPIDOGREL AND ASPIRIN.