FDA Adverse Event Injury Summary report: N

XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

MDR report key: 3082565 · Received April 29, 2013

Report

Report Number: 2024168-2013-02646
Event Type: Injury
Date Received: April 29, 2013
Date of Event: April 4, 2013
Report Date: April 17, 2013
Manufacturer: AV-TEMECULA-CT
Product Code: NIQ
PMA / PMN Number: P070015
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

Description of Event or Problem · 1

IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST XIENCE V STENT IMPLANTATION IN THE PROXIMAL LEFT MAIN CORONARY ARTERY, THE PATIENT EXPERIENCED CHEST PAIN, UNRELIEVED WITH NITROGLYCERIN AND PRESENTED TO THE EMERGENCY ROOM. ON (B)(6) 2013, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. ON (B)(6) 2013, THE EVENT WAS NOTED TO BE RESOLVED AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
183948	XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM	DRUG ELUTING CORONARY STENT SYSTEM	NIQ	AV-TEMECULA-CT		7091961

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| R