CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

Report

Report Number: 2015691-2010-14536
Event Type: Injury
Date Received: December 17, 2010
Date of Event: November 17, 2010
Report Date: November 18, 2010
Manufacturer: EDWARDS LIFESCIENCES
Product Code: DYE
PMA / PMN Number: P860057/S016
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL MANUFACTURER NARRATIVE: DUE TO THE LENGTH OF IMPLANT OF THE DEVICE AND THE RESULTS OF THE EVALUATION, IT WAS DEEMED UNNECESSARY TO DISMANTLE THE DEVICE FOR THE SERIAL NUMBER TO DO A DEVICE HISTORY RECORD (DHR) REVIEW.

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: HEAVY CALCIFICATION IS DETECTED IN THE CUSP AREA OF ALL THREE LEAFLETS. AT THE FREE MARGINS, CALCIFICATION IS MODERATE AT LEAFLET 1 AND MINIMAL TO MODERATE AT LEAFLET 2. CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. HOST TISSUE IS MINIMAL TO MODERATE AT THE STENT INFLOW AND STENT OUTFLOW. THE X-RAY DEMONSTRATES CALCIFICATION. THE VALVE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: CALCIFICATION IS A WELL RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. THE MECHANISMS FOR BIOPROSTHETIC HEART VALVE TISSUE CALCIFICATION ARE NOT FULLY UNDERSTOOD. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IT IS WIDELY UNDERSTOOD THAT PATIENTS WITH CHRONIC RENAL DISEASE AND PRIOR HISTORY OF CALCIFIC STENOSIS OF THE NATIVE VALVE MAY BE PREDISPOSED TO BIOPROSTHETIC CALCIFICATION. HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME.

Additional Manufacturer Narrative · 1

METHOD/CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: SALES REP WAS TOLD THAT HE COULD NOT GET A COPY OF OPERATIVE REPORT BECAUSE THOSE RECORDS ARE NOW ELECTRONIC AND HOSPITAL WILL NOT RELEASE DUE TO PATIENT CONFIDENTIALITY POLICY. NO PATIENT HISTORY IS AVAILABLE TO US. NO IMPLANT DATE OR SERIAL NUMBER WAS REPORTED FOR THIS DEVICE; THEREFORE THE DHR REVIEW CANNOT BE DONE AT THIS TIME. HOWEVER, ONCE THE DEVICE HAS BEEN EVALUATED, IT WILL BE DISMANTLED TO GAIN THE SERIAL NUMBER AND THE REVIEW WILL BE DONE. INVESTIGATION IS ON-GOING.

Description of Event or Problem · 1

SALES REP RECEIVED A CALL FROM THE HOSPITAL THAT A DEVICE HAD BEEN EXPLANTED. THEY REPORTED THAT THE DEVICE HAD ORIGINALLY BEEN IMPLANTED SOMETIME IN 2002 AND PATIENT HAD HAD CAGB AT THE SAME PROCEDURE. HE RECENTLY PRESENTED WITH SHORTNESS OF BREATH AND LIMITED AMBULATION WHICH NECESSITATED THE REMOVAL AND REPLACEMENT OF THE DEVICE. NO INFORMATION WAS PROVIDED AS TO THE CONDITION OF THE DEVICE AT EXPLANT. PATIENT RECEIVED A 7300TFX-31MM AS A REPLACEMENT. THERE WAS NO FURTHER INFORMATION PROVIDED TO THE SALES REP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS	REPLACEMENT HEART VALVE	DYE	EDWARDS LIFESCIENCES	6900P

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Hospitalization\| R