ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Report
- Report Number
- 3002808486-2016-01202
- Event Type
- Death
- Date Received
- October 10, 2016
- Date of Event
- September 10, 2016
- Report Date
- May 2, 2018
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346878
- PMA / PMN Number
- P140016
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). EVENT IS BEING RE-INVESTIGATED BASED ON THE INFORMATION RECEIVED ON 15DEC2017 RELATED TO PATIENT DEATH. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: EVENT WAS REINVESTIGATED DUE TO ADDITIONAL INFORMATION RECEIVED 15DEC2017. THE INVESTIGATION IS BASED ON REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORDS AND THE INSTRUCTIONS FOR USE (IFU). BASED ON PREVIOUS AND NEW INFORMATION DISTAL THORACIC ANEURYSM GROWTH AND TYPE 1B ENDOLEAK WAS SECONDARY TO ANEURYSM INFECTION. SINCE THE BACTERIUM ENTEROBACTER CLOACAE USUALLY ONLY INFECTS IMMUNOCOMPROMISED PATIENTS AND COLONIZES HOSPITAL EQUIPMENT, AORTIC INFECTION IMAGED AS ABNORMAL AORTIC WALL ENHANCEMENT AT ONE MONTH LIKELY BEGAN DURING OR SOON AFTER IMPLANTATION. BASED ON THE LIMITED INFORMATION PROVIDED IN THIS COMPLAINT TO DATE IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED PATIENT DEATH. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION RECEIVED 15DEC2017: ON (B)(6) 2017 THE PATIENT WAS REPORTED DEAD (528 DAYS POST-PROCEDURE). THE SITES DESCRIPTION OF CAUSE OF DEATH: "RECURRENCE OF AN ENTEROBACTER CLOACAE AORTITIS COMPLICATED BY A LARGE LEFT PULMONARY ABSCESS IN CONTACT WITH THE AORTIC STENT AND MASSIVE HEMOPTYSIS WITH ACUTE RESPIRATORY DISTRESS." THE CIRCUMSTANCES SURROUNDING THE "PATIENT'S" DEATH: " PATIENT REFERRED TO THE EMERGENCY DEPARTMENT FOR PROGRESSIVE ONSET OF CHEST PAIN. DOCTORS CONCLUSION: RECURRENCE OF AN ENTEROBACTER CLOACAE AORTITIS COMPLICATED BY PULMONARY ABSCESS. ANTIBIOTIC TREATMENT WITH INTRAVENOUS CEFEPIME. HEMOPTYSIS OF GREAT ABUNDANCE FROM (B)(6) 2017 WITH SPONTANEOUS RESOLUTION. CT SCAN FROM (B)(6) 2017 SHOWS NO ENDOLEAK, NO MIGRATION OF THE STENT BUT A LARGE LEFT PULMONARY ABSCESS IN CONTACT WITH THE AORTIC STENT. IN FRONT OF THE CRITICAL STATE OF THE PATIENT, MULTIDISCIPLINARY DECISION OF PALLIATIVE TREATMENT WHICH MEANS, NO VASCULAR OR THORACIC SURGERY IF RECURRENCE OF HEMOPTYSIS. MASSIVE HEMOPTYSIS WITH ACUTE RESPIRATORY DISTRESS ON (B)(6) 2017 WITH COMFORT CARE. DEATH OF THE PATIENT ON (B)(6) 2017." THESE EVENTS THAT LED TO THE DEATH OF THE PATIENT WAS, BY PHYSICIANS, CONSIDERED RELATED TO THE DEVICE.
(B)(4) INVESTIGATION IS STILL IN PROGRESS.
(B)(4). SIMILAR TO DEVICE WITH 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS THE INVESTIGATION OF THIS COMPLAINT WAS ONLY BASED ON THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION ALONG WITH HISTORY RECORD OF THE DEVICE. THE DESCRIPTION OF EVENT STATES THAT THE PATIENT RECEIVED ONE PROXIMAL COMPONENT, EXPLAINING THE OCCURRENCE OF TYPE IB ENDOLEAK. ACCORDING TO THE IFU SENT WITH THE PRODUCT, THE USE OF THIS PRODUCT REQUIRES THE USE OF A DISTAL COMPONENT ALSO AS THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS A TWO-PIECE CYLINDRICAL ENDOVASCULAR GRAFT CONSISTING OF PROXIMAL AND DISTAL COMPONENTS. THE USE OF TWO COMPONENTS PROVIDES ACTIVE FIXATION AT BOTH THE PROXIMAL AND DISTAL SEAL SITES. NOTHING INDICATES THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
EXEMPTION NUMBER E2016032. (B)(4). NAME AND ADDRESS FOR IMPORTER SITE: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: REINVESTIGATION DUE TO ADDITIONAL INFORMATION PROVIDED. THE INVESTIGATION OF THIS COMPLAINT WAS BASED ON REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORDS AND THE INSTRUCTIONS FOR USE (IFU). BASED ON THE LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ANEURYSMAL DILATATION WITH DISTAL TYPE I ENDOLEAK. ON (B)(6) 2016, THE PATIENT RECEIVED A PROXIMAL COMPONENT (CATALOG # AND LOT # NOT REPORTED). NO ADDITIONAL PROCEDURES OR DEVICES WERE PERFORMED AT THE INDEX PROCEDURE. THE PATIENT DEVELOPED SEPSIS 13 DAYS POST-PROCEDURE AND WAS DISCHARGED ON (B)(6) 2016 (32 DAYS PP). ON (B)(6) 2016 (43 DAYS PP), THE PATIENT EXPERIENCED HEMOPTYSIS. ON (B)(6) 2016 (52 DAYS PP), THE PATIENT DEVELOPED MASSIVE HEMOPTYSIS WHICH RESULTED IN RESPIRATORY DISTRESS AND CARDIAC ARREST. ON (B)(6) 2016 (55 DAYS PP), THE PATIENT UNDERWENT A LEFT LOWER LOBECTOMY. THE PATIENT WAS EXTUBATED ON (B)(6) 2016 (58 DAYS PP) AND EXPERIENCED SOME DYSPNEA DUE TO LARYNGEAL EDEMA. ON (B)(6) 2016 (120 DAYS PP), THE PATIENT EXPERIENCED HEMOPTYSIS AND ACUTE PULMONARY EDEMA. A CT DONE THE SAME DAY SHOWED ANEURYSMAL DILATATION OF THE DESCENDING THORACIC AORTA WITH A DISTAL TYPE I ENDOLEAK. A SECONDARY INTERVENTION WAS PERFORMED ON (B)(6) 2016 (121 DAYS PP) WITH IMPLANTATION OF A ZTA 30-201 AS A DISTAL EXTENSION. THE PATIENT EXPERIENCED A CARDIAC ARREST DURING THE PROCEDURE, BUT RECOVERED AFTER EXTERNAL CARDIAC MASSAGE AND ADRENALINE. PATIENT OUTCOME: NO FURTHER INFORMATION HAS BEEN RECEIVED.
DESCRIPTION OF EVENT ACCORDING TO STUDY: ANEURYSMAL DILATATION WITH DISTAL TYPE I ENDOLEAK . ON (B)(6) 2016 THE PATIENT RECEIVED A PROXIMAL COMPONENT (CATALOG # AND LOT # NOT REPORTED). NO ADDITIONAL PROCEDURES OR DEVICES WERE PERFORMED AT THE INDEX PROCEDURE. THE PATIENT DEVELOPED SEPSIS 13 DAYS POST-PROCEDURE AND WAS DISCHARGED ON (B)(6) 2016 (32 DAYS PP). ON (B)(6) 2016 (43 DAYS PP), THE PATIENT EXPERIENCED HEMOPTYSIS. ON (B)(6) 2016 (52 DAYS PP), THE PATIENT DEVELOPED MASSIVE HEMOPTYSIS WHICH RESULTED IN RESPIRATORY DISTRESS AND CARDIAC ARREST. ON (B)(6) 2016 (55 DAYS PP), THE PATIENT UNDERWENT A LEFT LOWER LOBECTOMY. THE PATIENT WAS EXTUBATED ON (B)(6) 2016 (58 DAYS PP) AND EXPERIENCED SOME DYSPNEA DUE TO LARYNGEAL EDEMA. ON (B)(6) 2016 (120 DAYS PP), THE PATIENT EXPERIENCED HEMOPTYSIS AND ACUTE PULMONARY EDEMA. A CT DONE THE SAME DAY SHOWED ANEURYSMAL DILATATION OF THE DESCENDING THORACIC AORTA WITH A DISTAL TYPE I ENDOLEAK. A SECONDARY INTERVENTION WAS PERFORMED ON (B)(6) 2016 (121 DAYS PP) WITH IMPLANTATION OF A ZTA 30-201 AS A DISTAL EXTENSION. THE PATIENT EXPERIENCED A CARDIAC ARREST DURING THE PROCEDURE, BUT RECOVERED AFTER EXTERNAL CARDIAC MASSAGE AND ADRENALINE. PATIENT OUTCOME: A SECONDARY INTERVENTION WAS PERFORMED ON (B)(6) 2016 (121 DAYS PP) WITH IMPLANTATION OF A ZTA 30-201 AS A DISTAL EXTENSION. THE PATIENT EXPERIENCED A CARDIAC ARREST DURING THE PROCEDURE, BUT RECOVERED AFTER EXTERNAL CARDIAC MASSAGE AND ADRENALINE.
ADDITIONAL INFORMATION RECEIVED 08AUG2017: ADDITIONAL INFO ADDED TO ENTRY OF 13MAY2016: THE PATIENT RECEIVED A PROXIMAL COMPONENT ZTA-P-30-155; LOT # E3362613. ON (B)(6) 2016 (24 DAYS PP), THE 1 MONTH FOLLOW-UP CT WAS DONE WHICH SHOWED PERSISTENT ENHANCEMENT OF THE AORTIC WALL. THE PATIENT DEVELOPED SEPSIS 13 DAYS POST-PROCEDURE AND WAS DISCHARGED ON (B)(6) 2016 (32 DAYS PP). CONSIDERED AS NOT RELATED TO EITHER DEVICE NOR PROCEDURE ON (B)(6) 2016 (43 DAYS PP), THE PATIENT EXPERIENCED HEMOPTYSIS. CONSIDERED AS NOT RELATED TO EITHER DEVICE NOR PROCEDURE. ON (B)(6) 2016 (52 DAYS PP), THE PATIENT DEVELOPED MASSIVE HEMOPTYSIS WHICH RESULTED IN RESPIRATORY DISTRESS AND CARDIAC ARREST. CONSIDERED AS NOT RELATED TO EITHER DEVICE NOR PROCEDURE. ON (B)(6) 2016 (55 DAYS PP), THE PATIENT UNDERWENT A LEFT LOWER LOBECTOMY. THE PATIENT WAS EXTUBATED ON (B)(6) 2016 (58 DAYS PP) AND EXPERIENCED SOME DYSPNEA DUE TO LARYNGEAL EDEMA. CONSIDERED AS NOT RELATED TO EITHER DEVICE NOR PROCEDURE. ADDITIONAL INFO ADDED TO ENTRY OF 10SEP2016: THE PATIENT EXPERIENCED HEMOPTYSIS AND ACUTE PULMONARY EDEMA. A CT DONE THE SAME DAY SHOWED ANEURYSMAL DILATATION OF THE DESCENDING THORACIC AORTA WITH A DISTAL TYPE I ENDOLEAK. CONSIDERED AS NOT RELATED TO PROCEDURE BUT RELATED TO DEVICE. A SECONDARY INTERVENTION WAS PERFORMED ON (B)(6) 2016 (121 DAYS PP) WITH IMPLANTATION OF A ZTA-P-30-201; LOT # E3364804 AS A DISTAL EXTENSION. CONSIDERED AS NOT RELATED TO PROCEDURE BUT RELATED TO DEVICE. ON (B)(6) 2016 (132 DAYS PP), THE PATIENT HAD A BACTERIAL INFECTION OF ENTEROBACTER CLAOCOE. ON (B)(6) 2016 (143 DAYS PP), THE PATIENT DEVELOPED FECALOID VOMITING AND WAS FOUND TO HAVE A BOWEL OBSTRUCTION. ON (B)(6) 2016 (148 DAYS PP), THE PATIENT UNDERWENT SURGERY TO REPAIR AN AREA OF THE INTESTINES WHERE ABNORMAL HEALING BETWEEN THE INTESTINES HAD OCCURRED AND LED TO THE OCCLUSION. CONSIDERED AS NOT RELATED TO EITHER DEVICE NOR PROCEDURE. ON (B)(6) 2016 (168 DAYS PP), THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666550 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | 10827002346878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death| L| R |