FDA Adverse Event Injury Summary report: N

EDWARDS CERTITUDE DELIVERY SYSTEM

MDR report key: 11047012 · Received December 21, 2020

Report

Report Number
2015691-2020-15147
Event Type
Injury
Date Received
December 21, 2020
Date of Event
March 2, 2020
Report Date
November 26, 2020
Manufacturer
EDWARDS LIFESCIENCES
Product Code
NPT
PMA / PMN Number
P140031
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THROUGH THE REVIEW OF THE MEDICAL ARTICLE: " CUTANEOUS-PERICARDIAL FISTULA: RARE COMPLICATION OF TRANSAPICAL AORTIC VALVE REPLACEMENT - CASE REPORT AND LITERATURE REVIEW". CORRESPONDING AUTHOR ANDREI TARUS. A (B)(6) YEARS OLD MALE UNDERWENT TAVR VIA THE TA APPROACH. A 29MM EDWARDS SAPIEN 3 VALVE WAS SUCCESSFULLY DEPLOYED. TWO PLEDGET MATTRESS SUTURES WERE USED TO CLOSE THE INSERTION SITE. AFTER PROTAMINE ADMINISTRATION, ADDITIONAL BIOGLUE SURGICAL ADHESIVE (CRYOLIFE, INC., (B)(4)) WAS USED FOR COMPLETE HEMOSTASIS DUE TO PERSISTENT MILD BLEEDING. THE PERICARDIAL AND PLEURAL CAVITY WAS DRAINED. THE CHEST TUBES WERE REMOVED ON THE 8TH POSTOPERATIVE DAY BECAUSE OF THE PERSISTENT SEROUS DRAINAGE. TWO WEEKS AFTER DISCHARGE, HE DEVELOPED ASEPTIC WOUND SEROMA WHICH WAS DRAINED OUTSIDE OUR SERVICE. SIX MONTHS AFTER DISCHARGE, PATIENT RETURNED COMPLAINING ABOUT LEFT CHEST PAIN AND CHRONIC DRAINING SINUS LOCALIZED ON THE LEFT THORACOTOMY SCAR. CT SHOWED AN OBLIQUE "HOURGLASS"-SHAPE FISTULA CONNECTING THE HEART'S APEX AND CHEST WALL, A SMALL APICAL COLLECTION (13MM) WITH ADJACENT INFLAMMATORY INFILTRATION INVOLVING PLEDGET SUTURES. DURING SURGERY, THE FISTULOUS CANAL WAS MARKED WITH BLUE STAINS TO PREVENT ITS OPENING AND CONTAMINATION OF HEALTHY TISSUES (FIGURE 3). THE SMALL ASEPTIC ABSCESS WAS INCISED NEAR THE HEART APEX; RESIDUAL DEPOTS OF BIOGLUE(R) (CRYOLIFE, INC., KENNESAW, GA) AND PLEDGET SUTURES WERE REMOVED. THE CAVITY WAS DRAINED AND THE WOUND CLOSED ACCORDING TO ANATOMIC LAYERS. ADDITIONAL DRAINAGE WAS PLACED IN THE SUBCUTANEOUS TISSUE. LONG-TERM ANTIBIOTIC TREATMENT WAS PERFORMED WITH VANCOMYCIN FOR BACTERIAL ENDOCARDITIS PROPHYLAXIS. FURTHER EVOLUTION WAS UNEVENTFUL. NO RECURRENCE WAS OBSERVED 12 MONTHS AFTER DISCHARGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1515187 EDWARDS CERTITUDE DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES CERTITUDE DELIVERY SYSTEM UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 55 YR Required Intervention