APEX MONORAIL
Report
- Report Number
- 2134265-2010-01694
- Event Type
- Death
- Date Received
- April 22, 2010
- Date of Event
- March 24, 2010
- Report Date
- March 24, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- LOX
- PMA / PMN Number
- P860019
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MANUFACTURER, EVALUATION RESULT: DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. A DETAILED MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL IDENTIFIED A LONGITUDINAL TEAR IN THE BALLOON. THE TEAR WAS LOCATED APPROXIMATELY 5MM DISTAL TO THE DISTAL EDGE OF THE PROXIMAL MARKERBAND AND EXTENDED DISTALLY ALONG THE BALLOON FOR A TOTAL LENGTH OF APPROXIMATELY 1.5MM. A DETAILED EXAMINATION OF THE BALLOON MATERIAL AND PROXIMAL AND DISTAL MARKERBANDS COULD NOT IDENTIFY ANY ANOMALIES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THE TEAR. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B) (4)
DATE OF BIRTH, WEIGHT, DESCRIBE EVENT OR PROBLEM, OTHER RELEVANT HISTORY, UPN, DEVICE LOT NUMBER, THERAPY DATES AND DESC, PATIENT CODES: UPDATED (B) (4)
(B) (4)
IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, PATIENT DEATH OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50X12MM APEX BALLOON WAS ADVANCED TO THE RIGHT CORONARY ARTERY (RCA) FOR PREDILATION. THE BALLOON WAS INFLATED ONCE AT 14ATMS FOR 11 SECONDS AND THEN, A 3.0X15MM NON BSC STENT WAS SUCCESSFULLY IMPLANTED IN THE LESION. THE 2.50X12MM APEX BALLOON WAS THEN ADVANCED TO THE MID LAD FOR PREDILATION. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, BUT UPON INFLATION, IT WAS NOTED THAT THE BALLOON HAD BURST AND CONTRAST BLUSH WAS NOW VISIBLE. THE APEX BALLOON WAS WITHDRAWN INTO THE NON BSC GUIDE CATHETER, AND IT WAS NOTED THAT THE VESSEL HAD PERFORATED AND THE LAD HAD LOST BLOOD FLOW. THE PATIENT WENT INTO CARDIAC ARREST AND CPR WAS STARTED. THE PATIENT WAS INTUBATED AND A BALLOON PUMP WAS PLACED. CPR WAS PERFORMED FOR 20 MINUTES AND TIMI III FLOW WAS RESTORED TO THE LAD; HOWEVER, THE PATIENT WAS STILL IN CARDIOGENIC SHOCK AND THE PHYSICIAN FEARED THAT THE PATIENT HAD BRAIN DAMAGE AS CONSCIOUSNESS WAS NOT REGAINED. ON RETURN FROM THE CARDIAC CATHETERIZATION LAB, THE PATIENT EXPIRED IN THE INTENSIVE CARE UNIT. IN THE OPINION OF THE PHYSICIAN, THE ASSESSMENT OF THE RELATIONSHIP OF DEVICE PERFORMANCE TO THE EVENT WAS THAT THERE WAS A "CORRELATION BETWEEN DEVICE FAILURE AND NO FLOW IN THE LAD".
IT WAS FURTHER REPORTED THAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS A 9MM, 99% STENOSED LESION WITH TIMI 2 FLOW PRE-PROCEDURE. FOLLOWING PREDILATION, A 3.0X15MM NON BSC STENT WAS DEPLOYED IN THE RCA AT 12ATMS FOR 11 SECONDS. A 3.0X8MM QUANTUM MAVERICK BALLOON WAS THEN INFLATED IN THE LESION AT 14ATMS FOR 10 SECONDS FOLLOWED BY INFLATION OF A 2.5X15MM APEX BALLOON FOR 19 SECONDS. AFTER TREATMENT IN THE RCA, TIMI 3 FLOW WAS PRESENT. THE PREVIOUSLY USED 2.50X12MM APEX BALLOON WAS THEN ADVANCED TO THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH WAS AN 8MM, 75% STENOSED LESION WITH TIMI 3 FLOW PRE-PROCEDURE. IT BECAME APPARENT AFTER INFLATION OF THE APEX BALLOON THAT THE BALLOON HAD RUPTURED, RESULTING IN TRANSIENT NO REFLOW TO THE LAD AND LEADING TO AN ¿EMD ARREST SITUATION¿. AN EKG CONFIRMED HYPOKINESIS OF THE ANTERIOR WALL DUE TO THE TRANSIENT LOSS OF BLOOD FLOW IN THE LAD. THE PATIENT WAS BROUGHT TO THE CRITICAL CARE UNIT; HOWEVER, THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP DESPITE LARGE DOSES ON ADRENALINE AND NORADRENALINE. IT BECAME APPARENT THAT THE PATIENT¿S BLOOD PRESSURE VARIATIONS WERE NOT LIFE SUSTAINABLE AND THE PATIENT WAS TAKEN OFF OF LIFE SUPPORT AND EXPIRED.
IT WAS FURTHER REPORTED THAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WAS A 9MM, 99% STENOSED LESION WITH TIMI 2 FLOW PRE-PROCEDURE. FOLLOWING PREDILATION, A 3.0X15MM NON BSC STENT WAS DEPLOYED IN THE RCA AT 12ATMS FOR 11 SECONDS. A 3.0X8MM QUANTUM MAVERICK BALLOON WAS THEN INFLATED IN THE LESION AT 14ATMS FOR 10 SECONDS FOLLOWED BY INFLATION OF A 2.5X15MM APEX BALLOON FOR 19 SECONDS. AFTER TREATMENT IN THE RCA, TIMI 3 FLOW WAS PRESENT. THE PREVIOUSLY USED 2.50X12MM APEX BALLOON WAS THEN ADVANCED TO THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH WAS AN 8MM, 75% STENOSED LESION WITH TIMI 3 FLOW PRE-PROCEDURE. IT BECAME APPARENT AFTER INFLATION OF THE APEX BALLOON THAT THE BALLOON HAD RUPTURED, RESULTING IN TRANSIENT NO REFLOW TO THE LAD AND LEADING TO AN ¿EMD ARREST SITUATION¿. AN EKG CONFIRMED HYPOKINESIS OF THE ANTERIOR WALL DUE TO THE TRANSIENT LOSS OF BLOOD FLOW IN THE LAD. THE PATIENT WAS BROUGHT TO THE CRITICAL CARE UNIT; HOWEVER, THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP DESPITE LARGE DOSES ON ADRENALINE AND NORADRENALINE. IT BECAME APPARENT THAT THE PATIENT¿S BLOOD PRESSURE VARIATIONS WERE NOT LIFE SUSTAINABLE, AND THE PATIENT WAS TAKEN OFF OF LIFE SUPPORT AND EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MONORAIL | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS | LOX | BOSTON SCIENTIFIC - GALWAY | H7493895912250 | 13201729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death | 6F CORDIS AVANTI+ INTRODUCER SHEATH| MERIT MEDICAL BASIX R COMPAK INFLATION DEVICE| ABBOTT PILOT 50, 0.014 190CM GUIDE WIRE| 3.0X15MM DRIVER SPRINT STENT| MEDTRONIC LAUNCHER 6F EBU3.5 GUIDE CATHETER |