ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
Report
- Report Number
- 3002808486-2016-00262
- Event Type
- Death
- Date Received
- May 18, 2016
- Date of Event
- April 25, 2016
- Report Date
- May 11, 2016
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002346434
- PMA / PMN Number
- P140016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: THE REPORTED INFORMATION FOR THIS COMPLAINT SUGGESTED DEATH OF THE PATIENT DUE TO ANAPHYLACTIC SHOCK (TYPE 1 HYPERSENSITIVITY REACTION) RELATED TO THE DEVICE, ZTA-. THE PATIENT EXPERIENCED A SUDDEN AND DRAMATIC CIRCULATORY COLLAPSE APPROXIMATELY TEN MINUTES AFTER PLACING THE FIRST DEVICE ACCOMPANIED BY LINGUAL AND LABIAL SWELLING OBSERVED DURING THE RECOVERY. THESE SYMPTOMS ARE CONSISTENT WITH HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS; NO FURTHER CLINICAL EXAMINATION OR DIAGNOSTIC TESTS WERE CONDUCTED TO CONFIRM THE SUSPECTED DIAGNOSIS OF TYPE 1 HYPERSENSITIVITY REACTION. MAINTAINING PHYSIOLOGIC BLOOD PRESSURE AT A LEVEL TO ENSURE SUFFICIENT TISSUE PERFUSION IS A CHALLENGE IN ALL PATIENTS UNDERGOING GENERAL ANESTHESIA, ESPECIALLY IN PATIENTS SUFFERING FROM SEVERE SYSTEMIC DISEASE. IN CASES OF PERSISTENT HYPOTENSION WITH NO OR LIMITED TREATMENT RESPONSE A TYPE 1 HYPERSENSITIVITY REACTION MUST BE SUSPECTED AS A POSSIBLE CAUSE. A TYPE 1 HYPERSENSITIVITY REACTION MAY OCCUR AS A SEVERE AND IMMEDIATE RESPONSE AFTER EXPOSURE TO A VAST NUMBER OF ALLERGENS. BASED ON THE CURRENT INFORMATION WE HAVE NOT BEEN ABLE TO DETERMINE IF THE IMPLANTED AORTIC GRAFT WAS RESPONSIBLE FOR THE REPORTED ANAPHYLACTIC SHOCK. BIOLOGICAL TESTING IN COMPLIANCE WITH (B)(4) HAS BEEN PERFORMED ON THE MATERIALS COMPRISING THE ZTA- GRAFT. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION OR INSUFFICIENT IFU. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.
(B)(4). PT IDENTIFIER ) UNKNOWN AS INFORMATION WAS NOT PROVIDED. AGE AT TIME OF EVENT, DATE OF BIRTH) UNKNOWN AS INFORMATION WAS NOT PROVIDED. WEIGHT) UNKNOWN AS INFORMATION WAS NOT PROVIDED. IMPLANT DATE) UNKNOWN AS INFORMATION WAS NOT PROVIDED. DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.
(B)(4). PT IDENTIFIER) UNKNOWN AS INFORMATION WAS NOT PROVIDED. WEIGHT) UNKNOWN AS INFORMATION WAS NOT PROVIDED. IMPLANT DATE) UNKNOWN AS INFORMATION WAS NOT PROVIDED. DEVICE IS SIMILAR TO DEVICE WITH 510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE PHYSICIAN MEANS THAT THERE WAS AN ANAPHYLACTIC SHOCK FROM THE GRAFTS. THE PATIENT DIED A FEW DAYS LATER. ADDITIONAL INFORMATION RECEIVED: A HEMODYNAMIC COLLAPSE OCCURED 10 MINUTES AFTER DEPLOYMENT OF THE FIRST STENT GRAFT. THE PATIENT WAS RESUSCITATED AND THE PROCEDURE WAS ENDED PROMPTLY AFTER DEPLOYMENT OF THE SECOND ENDOPROSTHESIS. POSTOPERATIVE CTA REVEALED NO ANATOMIC CORRELATE. ACCORDING TO PHYSICIAN THE PATIENT HAD A TYPE I THORACOABDOMINAL AORTIC ANEURYSM THAT THEY WERE PLANNING TO TREAT WITH A T-BRANCH DEVICE. HE WAS PREPARING THE ¿LANDING¿ ZONE BY FIRST PLACING A TX2 MAIN BODY. THERE WAS NOTHING UNUSUAL ABOUT THE DEPLOYMENT, BUT ABOUT TEN MINUTES AFTER IT WAS PLACED THE PATIENT EXPERIENCED A SUDDEN AND DRAMATIC CIRCULATORY COLLAPSE, CONSISTENT WITH AN ANAPHYLACTIC REACTION, AND WITH NO OTHER OBVIOUS CAUSE (FOR EXAMPLE, ULTRASOUND OF THE HEART DEMONSTRATED ADEQUATE FUNCTION; HIGH CARDIAC OUTPUT). THEY ATTEMPTED TO ADDRESS THE CIRCULATORY COLLAPSE WITH THE USUAL COCKTAIL OF MEDICATIONS (STEROIDS, ANTIHISTAMINES, EPINEPHRINE, ETC.) BUT WERE HAVING GREAT DIFFICULTY IN GETTING HER BLOOD PRESSURE BACK UP. THEY CONTINUED WITH PLACEMENT OF A PROXIMAL EXTENSION, BUT THEN ABORTED THE PROCEDURE BECAUSE OF THE ONGOING ANAPHYLACTIC RESPONSE. IN THE RECOVERY ROOM THEY ALSO NOTED SWOLLEN TONGUE AND LIPS, WHICH ARE CONSISTENT WITH AN ANAPHYLACTIC RESPONSE. IN THE ICU AFTER THE PROCEDURE THE PATIENT HAD SIGNS OF BOWEL ISCHEMIA/INFARCTION SO THEY TOOK HER TO THE OR WHERE THEY ORIGINALLY FOUND HEALTHY SMALL INTESTINE BUT DEAD LARGE INTESTINE WHICH WAS RESECTED. A COUPLE OF DAYS LATER THEY TOOK A SECOND LOOK AND PORTIONS OF SMALL INTESTINE ALSO DEAD, AND RESECTED. THE PATIENT DIED ON POST-OP DAY 4; PATHOLOGY DID NOT SHOW ANY SIGNS OF THROMBOTIC MESENTERIC VESSELS SO PRESUMABLY THE DEAD GUT WAS NOT DUE TO VESSELS FEEDING THE GUT HAVING BEEN BLOCKED, BUT INSTEAD DUE TO PROLONGED HYPOTENSION/SHOCK. PATIENT DID NOT HAVE ANY KNOWN ALLERGIES AND HAD NOT HAD REACTIONS TO CONTRAST MEDIA IN THE PAST, SO THEY¿RE ASSUMING THE REACTION WAS AN ANAPHYLACTIC RESPONSE TO SOME MATERIAL IN THE GRAFT. PATIENT OUTCOME: A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY: THE DESCENDING STENT DEVICES WERE PLACED AT THE CORRECT POSITION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE: COLECTOMY AND SMALL BOWEL RESECTION. THE PATIENT DIED A FEW DAYS LATER. WE ASSUME A FULMINANT ANAPHYLACTIC REACTION TO THE DEVICES.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE PHYSICIAN MEANS THAT THERE WAS AN ANAPHYLACTIC SHOCK FROM THE GRAFTS. THE PATIENT DIED A FEW DAYS LATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. PATIENT OUTCOME: A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY: THE DESCENDING STENT DEVICES WERE PLACED AT THE CORRECT POSITION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: THE PATIENT DIED A FEW DAYS LATER.
DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE PHYSICIAN MEANS THAT THERE WAS AN ANAPHYLACTIC SHOCK FROM THE GRAFTS. THE PATIENT DIED A FEW DAYS LATER. ADDITIONAL INFORMATION RECEIVED: A HEMODYNAMIC COLLAPSE OCCURED 10 MINUTES AFTER DEPLOYMENT OF THE FIRST STENT GRAFT. THE PATIENT WAS RESUSCITATED AND THE PROCEDURE WAS ENDED PROMPTLY AFTER DEPLOYMENT OF THE SECOND ENDOPROSTHESIS. POSTOPERATIVE CTA REVEALED NO ANATOMIC CORRELATE. ACCORDING TO PHYSICIAN THE PATIENT HAD A TYPE I THORACOABDOMINAL AORTIC ANEURYSM THAT THEY WERE PLANNING TO TREAT WITH A T-BRANCH DEVICE. HE WAS PREPARING THE "LANDING" ZONE BY FIRST PLACING A TX2 MAIN BODY. THERE WAS NOTHING UNUSUAL ABOUT THE DEPLOYMENT, BUT ABOUT TEN MINUTES AFTER IT WAS PLACED THE PATIENT EXPERIENCED A SUDDEN AND DRAMATIC CIRCULATORY COLLAPSE, CONSISTENT WITH AN ANAPHYLACTIC REACTION, AND WITH NO OTHER OBVIOUS CAUSE (FOR EXAMPLE, ULTRASOUND OF THE HEART DEMONSTRATED ADEQUATE FUNCTION; HIGH CARDIAC OUTPUT). THEY ATTEMPTED TO ADDRESS THE CIRCULATORY COLLAPSE WITH THE USUAL COCKTAIL OF MEDICATIONS (STEROIDS, ANTIHISTAMINES, EPINEPHRINE, ETC.) BUT WERE HAVING GREAT DIFFICULTY IN GETTING HER BLOOD PRESSURE BACK UP. THEY CONTINUED WITH PLACEMENT OF A PROXIMAL EXTENSION, BUT THEN ABORTED THE PROCEDURE BECAUSE OF THE ONGOING ANAPHYLACTIC RESPONSE. IN THE RECOVERY ROOM THEY ALSO NOTED SWOLLEN TONGUE AND LIPS, WHICH ARE CONSISTENT WITH AN ANAPHYLACTIC RESPONSE. IN THE ICU AFTER THE PROCEDURE THE PATIENT HAD SIGNS OF BOWEL ISCHEMIA/INFARCTION SO THEY TOOK HER TO THE OR WHERE THEY ORIGINALLY FOUND HEALTHY SMALL INTESTINE BUT DEAD LARGE INTESTINE WHICH WAS RESECTED. A COUPLE OF DAYS LATER THEY TOOK A SECOND LOOK AND PORTIONS OF SMALL INTESTINE ALSO DEAD, AND RESECTED. THE PATIENT DIED ON POST-OP DAY 4; PATHOLOGY DID NOT SHOW ANY SIGNS OF THROMBOTIC MESENTERIC VESSELS SO PRESUMABLY THE DEAD GUT WAS NOT DUE TO VESSELS FEEDING THE GUT HAVING BEEN BLOCKED, BUT INSTEAD DUE TO PROLONGED HYPOTENSION/SHOCK. PATIENT DID NOT HAVE ANY KNOWN ALLERGIES AND HAD NOT HAD REACTIONS TO CONTRAST MEDIA IN THE PAST, SO THEY'RE ASSUMING THE REACTION WAS AN ANAPHYLACTIC RESPONSE TO SOME MATERIAL IN THE GRAFT. PATIENT OUTCOME: A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY: THE DESCENDING STENT DEVICES WERE PLACED AT THE CORRECT POSITION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE: COLECTOMY AND SMALL BOWEL RESECTION. THE PATIENT DIED A FEW DAYS LATER. WE ASSUME A FULMINANT ANAPHYLACTIC REACTION TO THE DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317532 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | 10827002346434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |