FDA Adverse Event Death Summary report: N

PLICATOR

MDR report key: 634053 · Received August 29, 2005

Report

Report Number
634053
Event Type
Death
Date Received
August 29, 2005
Date of Event
June 9, 2005
Report Date
August 29, 2005
Manufacturer
NDO SURGICAL, INC
Product Code
KOG
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PT. ADMITTED TO G.I. CLINIC 6/2005 FOR NDO PLICATOR PROCEDURE FOR SEVERE INTRACTABLE GERD. POST PROCEDURE PATIENT WAS COMPLAINING OF STERNUM/ABDOMINAL PAIN LEVEL 8/10. PAIN REMAINED AT SAME LEVEL AFTER TWO DOSES OF IV MORPHINE. THE PAIN INCREASED WITH DEEP INSPIRATION. ON THE POST PROCEDURE PHONE CALL THE NEXT MORNING THE PATIENT COMPLAINED OF MID CHEST AND BACK PAIN AT 10/10 ESPECIALLY WHEN TAKING DEEP BREATHS. SHE HAD ALREADY SPOKEN TO HER DOCTOR AND WAS TAKING PAIN PILLS AS ORDERED. ON 6/2005 PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND WAS ADMITTED FOR LOWER LEFT LOBE PNEUMONIA. PATIENT WAS SEEN BY A PULMONOLOGIST ON 6/2005 WHO THOUGHT IT WAS LIKELY SHE HAD A PERFORATED DISTAL ESOPHAGUS OR THAT SHE COULD HAVE HAD A MICROPERFORATION THAT WAS ALREADY SEALED. HE STATES,"CLEARLY SHE HAD AN INFLAMMATORY PROCESS OF HER MEDIASTIUM AND LEFT PLEURAL SPACE WITH PAIN, CHEST X-RAY ABNORMALITIES, FEVER AND ELEVATED WHITE COUNT." HE ALSO THOUGHT SHE MIGHT HAVE AN ASPIRATION PNEUMONIA. THE GASTROENTEROLOGIST RULED OUT A PERFORATION AS THE PATIENT NEVER HAD FREE AIR UNDERNEATH THE DIAPHRAGM OR ANY INTRAABDOMINAL DISEASE IN THE AREA OF THE PLICATION PROCEDURE. ON 6/15 THE PATIENT HAD A FULL RESPIRATORY ARREST AND WAS PLACED ON A VENT. SHE EXPIRED ON 6/20. THE AUTOPSY REPORT STATES THE FINAL DIAGNOSIS IS ARDS DUE TO INHALATION OF FOOD/VOMITUS. THE ESOPHAGUS, STOMACH AND G-E JUNCTION ARE NOTABLE FOR POST PROCEDURE CHANGES, HOWEVER THE AREA IS INTACT WITHOUT EVIDENCE OF RUPTURE OR DEHISCENCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PLICATOR FULL THICKNESS ENDOSCOPIC PLICATION SYSTEM KOG NDO SURGICAL, INC * *

Patients

Seq Age Sex Outcome Treatment
1 71 YR Death