UNKNOWN
Report
- Report Number
- 1820334-2023-01335
- Event Type
- Injury
- Date Received
- October 4, 2023
- Report Date
- December 20, 2023
- Manufacturer
- COOK INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: IT WAS DISCOVERED ON (B)(6) 2023 DURING THE COURSE OF THE INVESTIGATION THAT THE DEVICES USED IN THE PROCEDURES WERE NOT COOK INCORPORATED MANUFACTURED DEVICES. THEREFORE, THE EVENT IS NOW NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS THE DEVICES ARE NOT SOLD IN THE US, AND THERE IS NOT A SAME/SIMILAR DEVICE MANUFACTURED BY COOK INC THAT IS MARKETED IN THE U.S. 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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
B3: DATE OF EVENT: 01JAN2016 TO 30NOV2021 E1: PHONE: (B)(6). 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 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN THE ARTICLE "EARLY AND MIDTERM OUTCOMES OF ENDOVASCULAR ANEURYSM REPAIR WITH ZENITH ALPHA ABDOMINAL STENT-GRAFT: RESULTS FROM A MULTICENTER RETROSPECTIVE TUSCANY REGISTRY" (TROISI ET AL) PUBLISHED IN THE JOURNAL OF ENDOVASCULAR THERAPY, IT WAS REPORTED THAT FOUR PATIENTS REQUIRED OPEN SURGICAL REPAIR FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC REPAIR (EVAR) PROCEDURES. "BETWEEN JANUARY 2016 AND NOVEMBER 2021, 265 PATIENTS UNDERWENT EVAR WITH ZENITH ALPHA ABDOMINAL IN 7 CENTERS OF VASCULAR SURGERY IN TUSCANY REGION, ITALY. DURING THE STUDY PERIOD, A TOTAL OF ABOUT 1850 EVARS HAS BEEN PERFORMED IN THE PARTICIPATING CENTERS BY 16 VASCULAR SURGEONS. ALL DATA WERE RETROSPECTIVELY COLLECTED AND MERGED IN A DEDICATED DATABASE. FOR THIS STUDY, WE INCLUDED PATIENTS WHO UNDERWENT ELECTIVE EVAR (202 PATIENTS, POPULATION STUDY). EXCLUSION CRITERIA WERE PREVIOUS OPEN AORTIC SURGERY, PREVIOUS EVAR OR OTHER ENDOVASCULAR PROCEDURE OF AORTOILIAC ARTERIES, MYCOTIC ANEURYSMS OR PRIMARY/SECONDARY AORTOENTERIC FISTULA, RUPTURED OR SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM (AAA), AND PLANNED ADJUNCTIVE ENDOVASCULAR PROCEDURES, INCLUDING CHIMNEY GRAFT AND DOUBLE BARREL TECHNIQUE. DUE TO THE RETROSPECTIVE NATURE OF THIS STUDY, ETHIC REVIEW WAS WAIVED. DIAGNOSES, ANATOMICAL FEATURES, AND OUTCOMES WERE ASSESSED ACCORDING TO THE REPORTING CRITERIA AND DEFINITIONS OF THE SOCIETY FOR VASCULAR SURGERY/INTERNATIONAL SOCIETY OF CARDIOVASCULAR SURGEONS." "TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL PASSAGE OF THE DELIVERY SYSTEM TO THE LANDING ZONE, ACCURATE PLACEMENT OF THE DEVICE IN THE TARGET ZONE, PROPER POSITIONING OF THE CONTRALATERAL LIMB AND COMPLETE WITHDRAWAL OF THE DELIVERY SYSTEM AFTER DEPLOYMENT WITHOUT SIGNIFICANT LIMB STENOSIS, FREEDOM FROM CONVERSION, AND ABSENCE OF TYPE I OR III ENDOLEAK. CLINICAL SUCCESS WAS DEFINED AS FREEDOM FROM ANEURYSM RUPTURE, EXPANSION (>5 MM), CONVERSION TO OPEN REPAIR, GRAFT INFECTION, AND ANEURYSM-RELATED DEATH. ALL PREOPERATIVE COMPUTED TOMOGRAPHY (CT)-SCANS WERE RETROSPECTIVELY EVALUATED, AND CENTER LUMEN LINE ANALYSIS WAS PERFORMED IN ALL CASES. HOSTILE NECK ANATOMY17 WAS DEFINED AS THE PRESENCE OF AT LEAST ONE OF THE FOLLOWING FEATURES: (1) A LENGTH BETWEEN THE MOST CAUDAL RENAL ARTERY AND THE BEGINNING OF THE ANEURYSM SAC =10 MM (SHORT NECK), (2) A FOCAL ENLARGEMENT OF THE NECK OF AT LEAST 3 MM WITHIN THE FIRST 15 MM AFTER THE MOST CAUDAL RENAL ARTERY (NECK BULGE), (3) A GRADUAL DILATION =2 MM OF THE NECK WITHIN THE FIRST 10 MM (TAPERED NECK), (4) INFRARENAL AAA NECK ANGULATION OF AT LEAST 60° WITHIN THE SEAL ZONE OF THE PROXIMAL NECK (ANGULATED NECK), AND (5) THROMBUS COVERING MORE THAN 50% OF THE CIRCUMFERENCE OF THE NECK (NECK THROMBUS). IN PARTICULAR, AAA NECK LENGTH WAS DEFINED AS THE LONGITUDINAL DISTANCE BETWEEN THE FIRST TRANSVERSE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SLICE DIRECTLY DISTAL TO THE LOWERMOST RENAL ARTERY AND THE FIRST TRANSVERSE CTA SLICE THAT SHOWED AT LEAST A 15% LARGER OUTER AORTIC WALL DIAMETER VERSUS THE DIAMETER MEASURED DIRECTLY BELOW THE LOWERMOST RENAL ARTERY, WHEREAS INFRARENAL AAA NECK ANGULATION WAS DEFINED AS THE TRUE ANGLE BETWEEN THE LONGITUDINAL AXIS OF THE PROXIMAL AAA NECK AND THE LONGITUDINAL AXIS OF THE AAA LUMEN, AS ANALYZED ON THREE-DIMENSIONAL CTA RECONSTRUCTIONS." "IN ALL CASES, FOLLOW-UP PROTOCOL INCLUDED PHYSICAL EXAMINATION AND DUPLEX ULTRASOUND (DUS) AT DISCHARGE. THE CTA WAS THEN PERFORMED AT 1 MONTH, AT 1 YEAR, AND YEARLY THEREAFTER, WHEREAS DUS WAS PERFORMED BETWEEN 3 AND 6 MONTHS AFTER THE INDEX PROCEDURE, AND YEARLY THEREAFTER. IN FEW CENTERS, CONTRAST-ENHANCED ULTRASOUND (CEUS) WAS USED IN SELECTED CASES WITH HIGH SUSPICION OF TYPE II ENDOLEAK AND SAC ENLARGEMENT." "PATIENTS WERE PREDOMINANTLY MALE (181, 89.6%) WITH A MEAN AGE OF 78.2±7.2 YEARS. TABLE 1 SUMMARIZES DEMOGRAPHIC AND PREOPERATIVE CLINICAL DATA. ALL PATIENTS PERFORMED A CTA OF THE THORACOABDOMINAL AORTA WITHIN 3 MONTHS BEFORE THE INTERVENTION TO GUARANTEE A CORRECT PLANNING AND POSSIBLY IDENTIFY OTHER VASCULAR LESIONS. TABLE 2 SHOWS PREOPERATIVE ANATOMICAL FEATURES. EIGHTY-FOUR (41.6%) PATIENTS HAD A HOSTILE ANATOMY OF THE PROXIMAL NECK. ALL ANATOMICAL FEATURES OF THE PROXIMAL NECK ARE LISTED IN TABLE 3. THIRTY-SIX PATIENTS (17.8%) WERE TREATED OUTSIDE IFU DUE TO A PROXIMAL NECK LENGTH LESS THAN 15 MM." "MOST OF THE PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA (95, 47%). FORTY-FOUR PATIENTS (21.8%) RECEIVED A LOCOREGIONAL ANESTHESIA, AND THE REMAINING 63 PATIENTS (31.2%) UNDERWENT THE PROCEDURE UNDER LOCAL ANESTHESIA. IN MOST CASES, THE STENT-GRAFT WAS DEPLOYED FROM BILATERAL SURGICAL FEMORAL ACCESS (160, 79.2%). IN THE REMAINING 42 PATIENTS (20.8%), A PERCUTANEOUS ACCESS WAS ADOPTED, USING PERCLOSE TECHNIQUE WITH A SYSTEM FROM ANOTHER MANUFACTURER. THE MEAN PROCEDURAL TIME WAS 126.1±51.8 MINUTES. THE MEAN OVERALL FLUOROSCOPY TIME WAS 18.2±13.1 MINUTES. THE MEAN TOTAL AMOUNT OF CONTRAST MEDIUM WAS 145±56.4 ML. ABOUT ILIAC LEGS, A ZISL CONFIGURATION WAS USED IN 134 CASES (66.3%), WHEREAS IN THE REMAINING 68 CASES (33.7%) A ZSLE DESIGN WAS CHOSEN. IN 31 CASES (15.3%), AN ADJUNCTIVE PROCEDURE WAS NECESSARY, CONSISTING IN HYPOGASTRIC EMBOLIZATION IN 7 CASES (3.5%), INTRA-GRAFT KISSING STENTING FOR NARROW AORTIC BIFURCATION IN 7 CASES (3.5%), ISOLATED STENTING OF EXTERNAL ILIAC ARTERY IN 8 CASES (4%), RENAL STENTING IN 5 CASES (2.5%), FEMORAL ENDARTERECTOMY IN 3 CASES (1.5%), AND COVERED STENTING OF A 2.8 CM RENAL ANEURYSM IN 1 CASE (0.5%). NO INTRAOPERATIVE SURGICAL CONVERSION OR DEATH OCCURRED. IN 3 CASES (1.5%), AN INTRAOPERATIVE TYPE IA ENDOLEAK WAS DETECTED, WHEREAS IN 1 CASE (0.5%) A FEMORO-FEMORAL CROSSOVER BYPASS WAS NEEDED TO MANAGE A LIMB GRAFT KINKING/THROMBOSIS. IN ADDITION, AT THE COMPLETION ANGIOGRAPHY, A TYPE II ENDOLEAK WAS DIAGNOSED IN 35 CASES (17.3%). "AFTER THE INTERVENTION, 26 PATIENTS (12.9%) WERE ADMITTED TO THE INTENSIVE CARE UNIT, WITH A MEDIAN STAY OF 48 HOURS (IQR: 24¿72). THE MEDIAN HOSPITAL STAY WAS 3 DAYS (IQR: 2¿4). TWENTY PATIENTS (9.9%) HAD A POST-IMPLANTATION SYNDROME WITH FEVER, LEUKOCYTOSIS, AND INCREASE OF C-REACTIVE PROTEIN LEVELS,19 WHICH COMPLETELY RESOLVED AFTER INTRAVENOUS CORTICOSTEROID THERAPY. FOUR PATIENTS (2%) HAD A TRANSITORY INCREASE OF CREATININE SERUM VALUE >20% OVER BASAL THRESHOLD, WHICH WAS CONSERVATIVELY TREATED. DURING HOSPITAL STAY, THE OTHER 3 PATIENTS HAD A LIMB GRAFT OCCLUSION (1.5%), WHICH WAS MANAGED WITH SURGICAL/ENDOVASCULAR THROMBECTOMY AND RELINING WITH STENTING OF EXTERNAL ILIAC ARTERY. IN ADDITION, 1 PATIENT (0.5%) UNDERWENT AN UNSUCCESSFUL AORTIC CUFF IMPLANTATION TO TREAT A TYPE IA ENDOLEAK; THIS PATIENT DIED DURING THE SECOND POSTOPERATIVE DAY DUE TO BOWEL ISCHEMIA. ONE PATIENT (0.5%) DEVELOPED A POSTOPERATIVE DEEP VENOUS THROMBOSIS WITH PULMONARY EMBOLISM AND ANOTHER ONE (0.5%) HAD AN IATROGENIC FEMORAL ARTERIOVENOUS FISTULA (CONSERVATIVE MANAGEMENT). THE 30 DAY OVERALL TECHNICAL AND CLINICAL SUCCESS RATES WERE 97.5% AND 99.5%, RESPECTIVELY." "FOLLOW-UP WAS AVAILABLE IN ALL PATIENTS WITH A MEDIAN FOLLOW-UP PERIOD OF 25.5 MONTHS (IQR: 12¿43.25). THE ESTIMATED 5YEAR OVERALL SURVIVAL WAS 73.6% (95% CI: 69.6%¿77.2%). OVERALL, 4 DEATHS (2%) HAVE BEEN CONSIDERED AAA-RELATED, WITH AN ESTIMATED FREEDOM FROM AAA RELATED DEATH OF 96.9% (95% CI: 94.7%¿98.1%). DURING THE FOLLOW-UP PERIOD, 4 (2%) OPEN SURGICAL CONVERSIONS OCCURRED. A FURTHER 6 PATIENTS (3%) HAD A LIMB GRAFT OCCLUSION. A GRAFT INFECTION WAS DIAGNOSED IN 2 PATIENTS (1%). NO TYPE III ENDOLEAK WAS DETECTED. IN ADDITION, THE OVERALL PREVALENCE OF TYPE II ENDOLEAK DURING THE FOLLOW-UP WAS 24.3% (49 CASES). AN ANEURYSMAL SAC SHRINKAGE MORE THAN 5 MM WAS FOUND IN 157 CASES (77.7%). THE ESTIMATED 5 YEAR OUTCOMES IN TERMS OF FREEDOM FROM TYPE I ENDOLEAK, FREEDOM FROM SURGICAL CONVERSION, FREEDOM FROM LIMB GRAFT OCCLUSION, FREEDOM FROM ANY DEVICE RELATED REINTERVENTIONS, AND FREEDOM FROM GRAFT INFECTION WERE 88.6% (95% CI: 83.4%¿93.1%), 95.8% (95% CI: 92.7%¿97.1%), 93.6% (95% CI: 90.2%¿96.8%), 87% (95% CI: 83.3%¿91.6%), AND 97.7% (95% CI: 95.1%¿98.9%), RESPECTIVELY (FIGURES 1 AND 2).ABOUT ZISL VERSUS ZSLE CONFIGURATION, NO DIFFERENCES WERE FOUND IN TERMS OF 5YEAR FREEDOM FROM LIMB GRAFT OCCLUSION (ZSLE 93.4% [95% CI: 89.8%¿95.5%] VS ZISL 94.3% [95% CI: 90.1%¿95.9%], P=0.342; LOG-RANK 0.903; FIGURE. 3). PATIENTS WHO UNDERWENT EVAR OUTSIDE IFU HAD LOWER 5YEAR SURVIVAL RATES (57.2% [95% CI: 51.8%¿64.3%] VS 76.7% [95% CI: 70.13%¿81.9%], P=0.009; LOG-RANK 6.858)." THIS REPORT REFERENCES THE FOUR PATIENTS WHO HAD OPEN SURGICAL REPAIR AFTER ENDOVASCULAR AORTIC REPAIR (EVAR). THIS INFORMATION WAS INCLUDED IN THE FIVE-YEAR OUTCOMES. ADDITIONAL REPORTS ARE SUBMITTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(4). LITERATURE CITATION: TROISI ET AL. (2023). EARLY AND MIDTERM OUTCOMES OF ENDOVASCULAR ANEURYSM REPAIR WITH ZENITH ALPHA ABDOMINAL STENT-GRAFT: RESULTS FROM A MULTICENTER RETROSPECTIVE TUSCANY REGISTRY. THE JOURNAL OF ENDOVASCULAR THERAPY, 1-8. DOI: 10.1177/15266028231197151.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467444 | UNKNOWN | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | ABBOTT PERCLOSE PROGLIDE| UNKNOWN COOK GRAFTS |