CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

Report

Report Number: 2015691-2010-13607
Event Type: Injury
Date Received: June 22, 2010
Date of Event: May 12, 2010
Report Date: June 2, 2010
Manufacturer: EDWARDS LIFESCIENCES
Product Code: KRH
PMA / PMN Number: K912554
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE NOT RETURNED.THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 06/03/2010 AND 06/10/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE THAT THE FILTER ON A CLEARLINK PACLITAXEL SET WAS CRACKED. THE CRACK IN THE FILTER WAS DISCOVERED DURING AN INFUSION OF REMICADE TO THE PATIENT, AND SOME OF THE DRUG LEAKED OUT. THERE WAS NO PATIENT INJURY, DRUG EXPOSURE OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. A NEW SOLUTION BAG WAS PREPARED WITH A NEW SET AND THE THERAPY WAS COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 115.43 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING	ANNULOPLASTY RING	KRH	EDWARDS LIFESCIENCES	4400	0G1129

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR		Required Intervention