FDA Adverse Event Injury Summary report: N

ENDEAVOR RX

MDR report key: 5322178 · Received December 23, 2015

Report

Report Number: 9612164-2015-01939
Event Type: Injury
Date Received: December 23, 2015
Report Date: December 6, 2015
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P060033
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CINE IMAGE REVIEW: THE IMAGES SHOW THE STENOSIS IN THE LMCA BEFORE PCI AND SHOW THE DEVELOPMENT OF A PSEUDOANEURYSM. THE IMAGES ALSO SHOW THE SPONTANEOUSLY REGRESSION OF THE PSEUDOANEURYSM. THE IMAGES DO NOT PROVIDE ANY ROOT CAUSE FOR THE EVENT. (B)(4).

Additional Manufacturer Narrative · 1

MINORU ICHIKAWA, YOSHIYUKI KIJIMA SPRINGER, 2014 TITLE: SPONTANEOUS RESOLUTION OF PSEUDOANEURYSM AFTER ZOTAROLIMUSELUTING STENT IMPLANTATION: IMAGING EVIDENCE AT 13 MONTHS OF FOLLOW-UP CARDIOVASC INTERV AND THER (2015) 30:168¿170 DOI 10.1007/S12928-014-0268-2.

Description of Event or Problem · 1

PHYSICIAN USED AN ENDEAVOR DRUG ELUTING STENT TO TREAT A DIFFUSE CALCIFIED STENOTIC LESION THAT EXTENDED FROM THE LEFT ANTERIOR DESCENDING ARTERY (LAD) TO THE LEFT MAIN CORONARY ARTERY (LMCA). LESION WAS PRE-DILATED AT PRESSURE OF 14ATM WITH A NON MEDTRONIC BALLOON. A DISSECTION OCCURRED AND WAS LEFT UNTREATED. THE ENDEAVOR STENT WAS THEN IMPLANTED AT PRESSURE OF 14 ATM, GOOD EXPANSION WAS ACHIEVED. THE PATIENT REMAINED ASYMPTOMATIC AFTER PCI. APPROXIMATELY 6 MONTHS POST PCI, FOLLOW-UP CAG AND IVUS REVEALED THE FORMATION OF AN IN-STENT PSEUDOANEURYSM CLOSER TO THE PROXIMAL END OF THE ENDEAVOR STENT. APPROXIMATELY 13 MONTHS POST THE INDEX PROCEDURE, CAG AND IVUS REVEALED THE SPONTANEOUS AND COMPLETE RESOLUTION OF THE PSEUDOANEURYSM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
848214	ENDEAVOR RX	STENT, CORONARY, DRUG-ELUTING	NIQ	MEDTRONIC IRELAND	EN35018X

Patients

Seq	Age	Sex	Outcome	Treatment
1	00069 YR		Hospitalization