UNKNOWN
Report
- Report Number
- 9680654-2024-00094
- Event Type
- Injury
- Date Received
- December 19, 2024
- Report Date
- January 23, 2025
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER DESPITE MULTIPLE REQUESTS, NO ADDITIONAL INFORMATION WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE CONDUCTED AS THE MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED DUE TO THE LOT NUMBER BEING UNKNOWN. REVIEW OF SPECIFICATIONS FOUND THAT THERE ARE A NUMBER OF CONTROLS AND PROCESSES IN PLACE THAT WOULD IDENTIFY FAULTY PRODUCT PRIOR TO SHIPPING. AS THE LOT NUMBER IS UNKNOWN, THE INVESTIGATOR REVIEWED THE INSTRUCTIONS FOR USE (IFU) CURRENTLY SUPPLIED WITH ZFEN (US) DEVICES FOR GENERAL INFORMATION WHICH WAS FOUND TO CONTAIN SUFFICIENT INSTRUCTIONS AND GUIDANCE INCLUDING: 4.1 GENERAL USE INFORMATION THE LONG-TERM PERFORMANCE OF FENESTRATED ENDOVASCULAR GRAFTS, INCLUDING THE STENTS PLACED IN FENESTRATIONS/SCALLOPS, HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS, CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT, OR STENOSIS/OCCLUSION OF VESSELS ACCOMMODATED BY FENESTRATIONS) SHOULD RECEIVE ENHANCED FOLLOW-UP. 5. ADVERSE EVENTS POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: - BLEEDING, HEMATOMA, OR COAGULOPATHY - VASCULAR SPASM OR VASCULAR TRAUMA (E.G., ILIOFEMORAL VESSEL DISSECTION, BLEEDING, RUPTURE), POTENTIALLY LEADING TO DEATH - AORTIC DAMAGE, INCLUDING PERFORATION, DISSECTION, BLEEDING, RUPTURE AND DEATH. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION RECEIVED A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE RECEIVED AT ANY TIME IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED, AND AN ADDITIONAL REPORT MAY BE SUBMITTED. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. EVENT INFORMATION TAKEN FROM REVIEW OF LITERATURE ARTICLE: ¿PREOPERATIVE PROTEINURIA IS INDEPENDENTLY ASSOCIATED WITH MORTALITY AFTER FENESTRATED ENDOVASCULAR ANEURYSM REPAIR¿. SHERNAZ S. DOSSABHOY ET AL 2024. DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2024.01.013. NOTE: GIVEN THAT MULTIPLE PAPERS CAN BE ADDRESSING THE SAME COHORT OF PATIENTS, DUPLICATES OF THE DATA MAY BE REPORTED AND THEREFORE THESE NUMBERS CAN BE OVERESTIMATING THE EVENTS. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.
EVENT INFORMATION TAKEN FROM REVIEW OF LITERATURE ARTICLE: PREOPERATIVE PROTEINURIA IS INDEPENDENTLY ASSOCIATED WITH MORTALITY AFTER FENESTRATED ENDOVASCULAR ANEURYSM REPAIR. SHERNAZ S. DOSSABHOY ET AL. 2024. DOI: HTTPS://DOI.ORG/10.1016/J.JVS.2024.01.013. NOTE: GIVEN THAT MULTIPLE PAPERS CAN BE ADDRESSING THE SAME COHORT OF PATIENTS, DUPLICATES OF THE DATA MAY BE REPORTED AND THEREFORE THESE NUMBERS CAN BE OVERESTIMATING THE EVENTS.
181 PATIENTS WHO UNDERWENT STANDARD FEVAR FROM 2012 TO 2022 ZFEN 96.7% P-BRANCH 3.3% ONLY STANDARD FEVAR, USING THE FOOD AND DRUG ADMINISTRATION-APPROVED COOK ZENITH FENESTRATED ENDOVASCULAR GRAFT (ZFEN; COOK MEDICAL, INC) OR CLINICAL TRIAL COOK ZENITH P-BRANCH DEVICE, A FENESTRATED ENDOGRAFT CONFIGURED WITH THREE FENESTRATIONS AND ONE SCALLOP, WERE INCLUDED. THOSE WITH ANY ADJUNCTIVE OFF-LABEL MODIFICATIONS (EG, CHIMNEY, SNORKEL, PERISCOPE, OR LASER FENESTRATION) WERE EXCLUDED. END POINT AND OUTCOMES. THE PRIMARY END POINT WAS LONG-TERM SURVIVAL, ASSESSED AS FREEDOM FROM ALL-CAUSE MORTALITY AT 1 AND 5 YEARS. LONG-TERM WAS DEFINED AS 5 YEARS IN THIS COHORT, CONSISTENT WITH PRIOR FEVAR LITERATURE. SECONDARY OUTCOMES INCLUDED PERIOPERATIVE COMPLICATIONS AT 30 DAYS (MYOCARDIAL INFARCTION, STROKE, BLEEDING OR HEMORRHAGIC SHOCK, PARALYSIS OR PARAPARESIS, AKI, BOWEL ISCHEMIA, LIMB ISCHEMIA, NEW-ONSET DIALYSIS, ACCESS COMPLICATION, TARGET ARTERY OCCLUSION, TYPE 1 OR 3 ENDOLEAK, REINTERVENTION, AND MORTALITY). ADDITIONAL END POINTS WERE ASSESSED AT LATEST FOLLOW-UP, INCLUDING ANEURYSM SAC REGRESSION, NUMBER OF IMAGING STUDIES (EITHER CTA, CT NONCONTRAST, OR ULTRASOUND EXAMINATION), EGFR DECLINE >30% OR NEW PERMANENT DIALYSIS, AND ANY REINTERVENTION. INDEPENDENT PREOPERATIVE PREDICTORS OF ALL-CAUSE LONG-TERM MORTALITY WERE EVALUATED WITH MULTIVARIABLE MODELING, AFTER ADJUSTING FOR BASELINE COVARIATES. OF 244 CONSECUTIVE PATIENTS WHO UNDERWENT FEVAR FROM 2012 TO 2022, 52 PATIENTS (21.3%) WERE EXCLUDED FOR OFF-LABEL MODIFICATIONS AND 11 PATIENTS (4.5%) FOR MISSING PREOPERATIVE URINALYSIS STUDIES. AMONG THE REMAINING 181 PATIENTS WHO CONSTITUTED THE STUDY COHORT, ANY PROTEINURIA WAS NOTED IN 30 PATIENTS (16.6%), WHEREAS 151 PATIENTS (83.4%) HAD NO EVIDENCE OF PROTEINURIA. OF THOSE WITH PROTEINURIA, 23 PATIENTS (77%) HAD 1Þ URINARY PROTEIN, 6 (20%) HAD 2Þ, AND 1 (3%) HAD 3Þ. OVERALL, TECHNICAL SUCCESS WAS 97.8%. OUTCOMES. THIRTY-DAY MORTALITY WAS SIGNIFICANTLY HIGHER IN THE PROTEINURIA GROUP (10.0% VS 1.3%; P ¼ .03) (FIG 2). NO STATISTICALLY SIGNIFICANT DIFFERENCES WERE OBSERVED IN ANY OTHER MAJOR 30-DAY ADVERSE EVENT, INCLUDING POSTOPERATIVE AKI (PROTEINURIA 10.0% VS NO PROTEINURIA 14.6%; P ¼ .77), TARGET ARTERY OCCLUSION (6.7% VS 4.0%; P ¼ .62), TYPE 1 OR 3 ENDOLEAK (0% VS 4.0%; P ¼ .59), OR REINTERVENTION AT 30 DAYS (10.0% VS 6.0%; P ¼ .42). THE PRIMARY OUTCOME, KAPLAN-MEIER ESTIMATE OF OVERALL SURVIVAL, WAS SIGNIFICANTLY LOWER FOR THE PROTEINURIA GROUP AT 1 YEAR (71.5% VS 92.3%; LOG-RANK P < .001) AND 5 YEARS (29.5% VS 68.1%; LOG-RANK P < .001). THE MEAN CLINICAL FOLLOW-UP FOR THE ENTIRE COHORT WAS 33.0 6 24.2 MONTHS. EARLY POSTOPERATIVE ADVERSE EVENTS (UP TO 30 DAYS) IN 103 PATIENTS THIS (B)(4) : RENAL COMPLICATIONS ¿ IN 51 PATIENTS - AKI IN 44 PATIENTS 24.6 % - NEW ONSET DIALYSIS IN 7 PATIENTS 4% SEE (B)(4): PROCEDURAL COMPLICATIONS ON 4 PATIENTS - MI MYOCARDIAL INFARCTION IN 3 PATIENTS 2% - ACCESS COMPLICATION IN 1 PATIENT 0.7% SEE (B)(4) FOR: BLEEDING OR HEMORRHAGIC SHOCK IN 1 PATIENT 0.7% (NOT DEATH RELATED) SEE (B)(4) FOR: BOWEL ISCHEMIA IN 14 PATIENTS 8% (NOT DEATH RELATED) SEE (B)(4) FOR: LIMB ISCHEMIA IN 7 PATIENTS 4% SEE (B)(4) FOR: TARGET ARTERY OCCLUSION IN 19 PATIENTS 10.7% SEE (B)(4) FOR: TYPE 1 OR 3 ENDOLEAK IN 7 PATIENTS 4% SEE (B)(4) FOR: SECONDARY INTERVENTION 29 OF THE PATIENTS TOTAL QUANTITY OF PATIENTS LISTED AS (B)(4), AS IT IS UNKNOWN HOW MANY PATIENTS HAD MULTIPLE EVENTS. (THE ACTUAL NUMBER OF PATIENTS IS LIKELY TO HAVE BEEN LESS) REINTERVENTION IN 29 OF THE PATIENTS 16% (NO DETAILS SUPPLIED) ANEURYSM RELATED DEATH IN 3 PATIENTS (1.7): SEE (B)(4) FOR: AORTIC GRAFT INFECTION IN 1 PATIENT (0.6) SEE (B)(4) FOR: CARDIOGENIC SHOCK AFTER REINTERVENTION IN 1 PATIENT (0.6) SEE (B)(4) FOR: RENAL STENT OCCLUSION, WHICH WAS COMPLICATED BY PERFORATION DURING ATTEMPTED EMBOLECTOMY AND HEMORRHAGIC SHOCK IN 1 PATIENT (0.6) EARLY MORTALITY (UP TO 30 DAYS) FIVE PATIENTS (2.8%) DIED WITHIN 30 DAYS OF FEVAR: THREE DEATHS OCCURRED IN THE PROTEINURIA GROUP (TWO DUE TO BOWEL ISCHEMIA AND ONE DUE TO LUNG CANCER) AND TWO DEATHS IN THOSE WITHOUT PROTEINURIA (ONE DUE TO BOWEL ISCHEMIA AND ONE DUE TO HEMORRHAGIC SHOCK). THESE 30-DAY DEATHS WERE DISTRIBUTED EVENLY ACROSS THE 10-YEAR STUDY PERIOD. TAKEN FROM SUPPLEMENTARY TABLE III (ONLINE ONLY). MORTALITY EVENTS DURING FOLLOW-UP BOWEL ISCHEMIA 3 PATIENTS (1.7) HEMORRHAGIC SHOCK 1 PATIENT (0.6) LUNG CANCER 1 (0.6) (NO PR AS LUNG CANCER IS NOT CAUSED OR CONTRIBUTED TO BY THE DEVICE OR PROCEDURE). SEE (B)(4): EARLY MORTALITY: BOWEL ISCHEMIA 3 PATIENTS (1.7) SEE (B)(4) FOR EARLY MORTALITY: HEMORRHAGIC SHOCK 1 PATIENT (0.6).
181 PATIENTS WHO UNDERWENT STANDARD FEVAR FROM 2012 TO 2022 ZFEN 96.7% P-BRANCH 3.3% ONLY STANDARD FEVAR, USING THE FOOD AND DRUG ADMINISTRATION-APPROVED COOK ZENITH FENESTRATED ENDOVASCULAR GRAFT (ZFEN; COOK MEDICAL, INC) OR CLINICAL TRIAL COOK ZENITH P-BRANCH DEVICE, A FENESTRATED ENDOGRAFT CONFIGURED WITH THREE FENESTRATIONS AND ONE SCALLOP, WERE INCLUDED. THOSE WITH ANY ADJUNCTIVE OFF-LABEL MODIFICATIONS (EG, CHIMNEY, SNORKEL, PERISCOPE, OR LASER FENESTRATION) WERE EXCLUDED. END POINT AND OUTCOMES. THE PRIMARY END POINT WAS LONG-TERM SURVIVAL, ASSESSED AS FREEDOM FROM ALL-CAUSE MORTALITY AT 1 AND 5 YEARS. LONG-TERM WAS DEFINED AS 5 YEARS IN THIS COHORT, CONSISTENT WITH PRIOR FEVAR LITERATURE. SECONDARY OUTCOMES INCLUDED PERIOPERATIVE COMPLICATIONS AT 30 DAYS (MYOCARDIAL INFARCTION, STROKE, BLEEDING OR HEMORRHAGIC SHOCK, PARALYSIS OR PARAPARESIS, AKI, BOWEL ISCHEMIA, LIMB ISCHEMIA, NEW-ONSET DIALYSIS, ACCESS COMPLICATION, TARGET ARTERY OCCLUSION, TYPE 1 OR 3 ENDOLEAK, REINTERVENTION, AND MORTALITY). ADDITIONAL END POINTS WERE ASSESSED AT LATEST FOLLOW-UP, INCLUDING ANEURYSM SAC REGRESSION, NUMBER OF IMAGING STUDIES (EITHER CTA, CT NONCONTRAST, OR ULTRASOUND EXAMINATION), EGFR DECLINE >30% OR NEW PERMANENT DIALYSIS, AND ANY REINTERVENTION. INDEPENDENT PREOPERATIVE PREDICTORS OF ALL-CAUSE LONG-TERM MORTALITY WERE EVALUATED WITH MULTIVARIABLE MODELING, AFTER ADJUSTING FOR BASELINE COVARIATES. OF 244 CONSECUTIVE PATIENTS WHO UNDERWENT FEVAR FROM 2012 TO 2022, 52 PATIENTS (21.3%) WERE EXCLUDED FOR OFF-LABEL MODIFICATIONS AND 11 PATIENTS (4.5%) FOR MISSING PREOPERATIVE URINALYSIS STUDIES. AMONG THE REMAINING 181 PATIENTS WHO CONSTITUTED THE STUDY COHORT, ANY PROTEINURIA WAS NOTED IN 30 PATIENTS (16.6%), WHEREAS 151 PATIENTS (83.4%) HAD NO EVIDENCE OF PROTEINURIA. OF THOSE WITH PROTEINURIA, 23 PATIENTS (77%) HAD 1Þ URINARY PROTEIN, 6 (20%) HAD 2Þ, AND 1 (3%) HAD 3Þ. OVERALL, TECHNICAL SUCCESS WAS 97.8%. OUTCOMES. THIRTY-DAY MORTALITY WAS SIGNIFICANTLY HIGHER IN THE PROTEINURIA GROUP (10.0% VS 1.3%; P ¼ .03) (FIG 2). NO STATISTICALLY SIGNIFICANT DIFFERENCES WERE OBSERVED IN ANY OTHER MAJOR 30-DAY ADVERSE EVENT, INCLUDING POSTOPERATIVE AKI (PROTEINURIA 10.0% VS NO PROTEINURIA 14.6%; P ¼ .77), TARGET ARTERY OCCLUSION (6.7% VS 4.0%; P ¼ .62), TYPE 1 OR 3 ENDOLEAK (0% VS 4.0%; P ¼ .59), OR REINTERVENTION AT 30 DAYS (10.0% VS 6.0%; P ¼ .42). THE PRIMARY OUTCOME, KAPLAN-MEIER ESTIMATE OF OVERALL SURVIVAL, WAS SIGNIFICANTLY LOWER FOR THE PROTEINURIA GROUP AT 1 YEAR (71.5% VS 92.3%; LOG-RANK P < .001) AND 5 YEARS (29.5% VS 68.1%; LOG-RANK P < .001). THE MEAN CLINICAL FOLLOW-UP FOR THE ENTIRE COHORT WAS 33.0 6 24.2 MONTHS. EARLY POSTOPERATIVE ADVERSE EVENTS (UP TO 30 DAYS) IN 103 PATIENTS. THIS (B)(4) FOR: BLEEDING OR HEMORRHAGIC SHOCK IN 1 PATIENT 0.7% (NOT DEATH RELATED). SEE (B)(4): PROCEDURAL COMPLICATIONS ON 4 PATIENTS - MI MYOCARDIAL INFARCTION IN 3 PATIENTS 2%, - ACCESS COMPLICATION IN 1 PATIENT 0.7%. SEE (B)(4) FOR: RENAL COMPLICATIONS ¿ IN 51 PATIENTS - AKI IN 44 PATIENTS 24.6 % - NEW ONSET DIALYSIS IN 7 PATIENTS 4%. SEE (B)(4) FOR: BOWEL ISCHEMIA IN 14 PATIENTS 8% (NOT DEATH RELATED). SEE (B)(4) FOR: LIMB ISCHEMIA IN 7 PATIENTS 4%. SEE (B)(4) FOR: TARGET ARTERY OCCLUSION IN 19 PATIENTS 10.7%. SEE (B)(4) FOR: TYPE 1 OR 3 ENDOLEAK IN 7 PATIENTS 4%. SEE (B)(4) FOR: SECONDARY INTERVENTION 29 OF THE PATIENTS. TOTAL QUANTITY OF PATIENTS LISTED AS 103, AS IT IS UNKNOWN HOW MANY PATIENTS HAD MULTIPLE EVENTS. (THE ACTUAL NUMBER OF PATIENTS IS LIKELY TO HAVE BEEN LESS) REINTERVENTION IN 29 OF THE PATIENTS 16% (NO DETAILS SUPPLIED). ANEURYSM RELATED DEATH IN 3 PATIENTS (1.7): SEE (B)(4) FOR: AORTIC GRAFT INFECTION IN 1 PATIENT (0.6). SEE (B)(4) FOR: CARDIOGENIC SHOCK AFTER REINTERVENTION IN 1 PATIENT (0.6). SEE (B)(4) FOR: RENAL STENT OCCLUSION, WHICH WAS COMPLICATED BY PERFORATION DURING ATTEMPTED EMBOLECTOMY AND HEMORRHAGIC SHOCK IN 1 PATIENT (0.6). EARLY MORTALITY (UP TO 30 DAYS). FIVE PATIENTS (2.8%) DIED WITHIN 30 DAYS OF FEVAR: THREE DEATHS OCCURRED IN THE PROTEINURIA GROUP (TWO DUE TO BOWEL ISCHEMIA AND ONE DUE TO LUNG CANCER) AND TWO DEATHS IN THOSE WITHOUT PROTEINURIA (ONE DUE TO BOWEL ISCHEMIA AND ONE DUE TO HEMORRHAGIC SHOCK). THESE 30-DAY DEATHS WERE DISTRIBUTED EVENLY ACROSS THE 10-YEAR STUDY PERIOD. TAKEN FROM SUPPLEMENTARY TABLE III (ONLINE ONLY). MORTALITY EVENTS DURING FOLLOW-UP BOWEL ISCHEMIA 3 PATIENTS (1.7) HEMORRHAGIC SHOCK 1 PATIENT (0.6) LUNG CANCER 1 (0.6) (NO PR AS LUNG CANCER IS NOT CAUSED OR CONTRIBUTED TO BY THE DEVICE OR PROCEDURE). SEE (B)(4): EARLY MORTALITY: BOWEL ISCHEMIA 3 PATIENTS (1.7). SEE (B)(4) FOR EARLY MORTALITY: HEMORRHAGIC SHOCK 1 PATIENT (0.6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2061614 | UNKNOWN | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM A. COOK AUSTRALIA, PTY LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |