XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Report

Report Number: 2024168-2008-00626
Event Type: Injury
Date Received: August 6, 2008
Report Date: July 7, 2008
Manufacturer: ABBOTT VASCULAR-CARDIAC THERAPIES
Product Code: NIQ
PMA / PMN Number: P070015
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

RESULTS AND CONCLUSION SUMMATION: DISSECTION, PER THE IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND NOT NECESSARILY AN INDICATION OF A PROD QUALITY ISSUE. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. ALSO, THE IFU STATES, "IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADD'L INTERVENTION (PLACEMENT OF ADD'L STENTS)." THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION, THEREFORE, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE CANNOT BE DETERMINED.

Description of Event or Problem · 1

REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT DURING DILATATION OF THE MID LAD, AFTER DEPLOYMENT OF THE XIENCE V STENT, A DISSECTION OCCURRED DISTAL FROM THIS STENT; THEREFORE, A SECOND UNPLANNED XIENCE V STENT WAS IMPLANTED THERE. NO PREDILATATION WAS PERFORMED, AS THERE WAS A CHANCE OF FURTHER DISSECTION OCCURRING. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM		NIQ	ABBOTT VASCULAR-CARDIAC THERAPIES	NA	7080661

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Required Intervention