UNKNOWN
Report
- Report Number
- 9680654-2022-00019
- Event Type
- Injury
- Date Received
- October 31, 2022
- Report Date
- December 19, 2022
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS REPORT IS RELATED TO (B)(4), (B)(4), (B)(4), AND (B)(4). THIS COMPLAINT WAS REPORTED IN A JOURNAL ARTICLE PUBLISHED BY L BERTOGLIO ET AL IN JOURNAL OF ENDOVASCULAR THERAPY 2018, VOL. 25(2) 230¿236. DOI: 10.1177/1526602817752449.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO IMAGES OR ADDITIONAL INFORMATION WAS RECEIVED TO ASSIST THE INVESTIGATION. THE JOURNAL ARTICLE WAS REVIEWED BY COOK¿S MEDICAL DIRECTOR WHO STATED: ¿THIS IS THE CASE REPORT OF TYPE 3C ENDOLEAK IN THORACOABDOMINAL ENDOGRAFT, WITH TYPE 3C ENDOLEAK BEING AROUND THE BRIDGING STENT AT THE FENESTRATIONS IN THE MAIN GRAFT BODY.¿ HE NOTED THAT THE BRIDGING STENTS INVOLVED IN ALL THE CASES OF TYPE 3C ENDOLEAKS WERE MANUFACTURED BY A DIFFERENT COMPANY TO THE STENTS COOK RECOMMENDS. COOK RECOMMENDS ATRIUM ICAST STENTS AS THESE HAVE BEEN TESTED WITH COOK¿S DEVICES. THE MEDICAL DIRECTOR STATED THAT: ¿ALL THE ENDOLEAKS INVOLVED THE LIFESTREAM STENTS. THEY WERE ALL SEALED WITH SECONDARY INTERVENTION AND FURTHER BALLOONING OF THE BRIDGING STENTS¿ I CAN¿T SEE ANY FAULT OR FAILURE OF THE COOK DEVICES IN THIS REPORT.¿ HE NOTED THAT THE ARTICLE REPORTED NO ENDOLEAKS WITH THE ICAST STENTS. HE COMMENTED THAT THE OTHER STENTS REQUIRE MORE FORCEFUL BALLOON DILATATION TO SEAL PROPERLY THE EDGES OF THE FENESTRATIONS THAN THE ICAST STENTS AND STATED: ¿IF THE INITIAL DILATATION OF THE LIFESTREAM STENTS WAS INSUFFICIENT, THAT EXPLAINS THE ENDOLEAKS. THIS WAS CORROBORATED BY THE FACT THAT FURTHER (EXTRA) BALLOON DILATATION FIXED THE PROBLEM IN ALL CASES." AS THE LOT NUMBERS WERE NOT PROVIDED FOR THE EVENTS IN THIS JOURNAL ARTICLE, A REVIEW OF THE WORK ORDERS AND SPECIFIC MANUFACTURING RECORDS FOR THE DEVICES USED WAS NOT ABLE TO BE CONDUCTED. BASED ON THE INFORMATION PROVIDED AND THE COMPLETED INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES ARE: INADEQUATE INTERACTION BETWEEN FENESTRATION AND BRIDGING STENT; PATIENT/PROCEDURE RELATED FACTORS.
A JOURNAL ARTICLE REPORTS OF TYPE IIIC ENDOLEAK FOLLOWING THORACOABDOMINAL AORTIC ANEURYSM (TAAA) REPAIR USING FENESTRATED AND BRANCHED STENT GRAFTS AND A NOVEL BALLOON-EXPANDABLE COVERED STENT. THE PROCEDURES WERE PERFORMED BETWEEN MARCH 2015 AND JANUARY 2017 ON HIGH-RISK SURGICAL CANDIDATES WITH A MEDIAN AGE OF 74.7 YEARS. TAAA WAS TREATED WITH MULTISTAGE F/BEVAR. CUSTOM-MADE OR OFF-THE-SHELF F/BEVAR DEVICES WERE CHOSEN BASED ON INDIVIDUAL ANATOMY. LIFESTREAM BALLOON-EXPANDABLE COVERED STENT IN ALL FENESTRATED DESIGNS IN THESE PATIENTS AND SELECTIVELY IN THE BRANCHED DESIGNS. FLUENCY SELF-EXPANDING STENT-GRAFTS WERE EMPLOYED IN ALL BRANCHED DESIGNS NOT MATED WITH THE LIFESTREAM COVERED STENT. THE BRIDGING STENT WAS SIZED ACCORDING TO THE DIAMETER OF THE TARGET VESSEL (NO OVERSIZING) AND THE LENGTH FROM THE FENESTRATION/BRANCH TO WITHIN THE TARGET VESSEL TO OBTAIN A MINIMUM 15-MM DISTAL LANDING ZONE. UNFRACTIONED HEPARIN WAS ADMINISTERED INTRAVENOUSLY BEFORE AND DURING THE PROCEDURE TO MAINTAIN AN ACTIVATED CLOTTING TIME >250 SECONDS. AFTER MAIN GRAFT DEPLOYMENT THE LIFESTREAMS WERE ADVANCED THROUGH A COMPATIBLE FLEXOR SHEATH (COOK MEDICAL) AND DEPLOYED IN THE INTENDED LOCATION EITHER PROTRUDING 5 TO 10 MM WITHIN THE MAIN GRAFT IN FENESTRATED DESIGNS OR OVERLAPPING INTO THE GARGET BRANCH (18-21 MM). PROXIMAL STENT FLARING WAS PERFORMED IN ALL FENESTRATIONS WITH A 10X20 MM NONCOMPLIANT BALLOON (ARMADA 35; ABBOTT VASCULAR, SANTA CLARA, CA, USA). IN BRANCHED CASES, PROXIMAL DILATION WAS PERFORMED ONLY IF THERE WAS A DIAMETER MISMATCH BETWEEN THE COVERED STENT AND THE BRANCH. IN THESE INSTANCES, A 6- OR 8-MM NON-COMPLIANT ARMADA 35 BALLOON WAS USED. PATIENTS WERE DISCHARGED ON DOUBLE ANTIPLATELET THERAPY WITH ASPIRIN AND AN ADENOSINE DIPHOSPHATE RECEPTOR ANTAGONIST FOR THE FIRST YEAR. FIVE PATIENTS HAD TYPE IIIC ENDOLEAKS. THE PATIENT HAD TYPE IIIC PERIFENESTRATION ENDOLEAK SECONDARY TO INADEQUATE SEALING OF THE LIFESTREAM STENT-GRAFT. THE TARGET VESSEL WITH ENDOLEAK HAD NOT RECEIVED PREVIOUS STENTING. THE PATIENT RECEIVED CT SCAN AT 2 MONTHS WHICH CONFIRMED PERSISTENCE OF THE ENDOLEAK. THE PATIENT UNDERWENT A SECONDARY ENDOVASCULAR REINTERVENTION UNDER LOCAL ANAESTHESIA. A 10X20 MM BALLOON WAS INFLATED AT THE LEVEL OF FENESTRATION WHILE AORTOGRAPHY WAS PERFORMED FROM THE CONTRALATERAL GROIN TO CONFIRM THE TYPE IIIC ENDOLEAK. THE TYPE IIIC ENDOLEAK WAS SEALED WITH PROXIMAL RELINING USING A BARE BALLOON-EXPANDABLE STENT AT THE PERI-FENESTRATION TRANSITION AREA. THE ENDOLEAK WAS COMPLETELY RESOLVED AT 6 AND 12 MONTHS FROM THE SECONDARY PROCEDURE.
A JOURNAL ARTICLE REPORTS OF TYPE IIIC ENDOLEAK FOLLOWING THORACOABDOMINAL AORTIC ANEURYSM (TAAA) REPAIR USING FENESTRATED AND BRANCHED STENT GRAFTS AND A NOVEL BALLOON-EXPANDABLE COVERED STENT. THE PROCEDURES WERE PERFORMED BETWEEN (B)(6) 2015 AND (B)(6) 2017 ON HIGH-RISK SURGICAL CANDIDATES WITH A MEDIAN AGE OF 74.7 YEARS. TAAA WAS TREATED WITH MULTISTAGE F/BEVAR. CUSTOM-MADE OR OFF-THE-SHELF F/BEVAR DEVICES WERE CHOSEN BASED ON INDIVIDUAL ANATOMY. LIFESTREAM BALLOON-EXPANDABLE COVERED STENT IN ALL FENESTRATED DESIGNS IN THESE PATIENTS AND SELECTIVELY IN THE BRANCHED DESIGNS. FLUENCY SELF-EXPANDING STENT-GRAFTS WERE EMPLOYED IN ALL BRANCHED DESIGNS NOT MATED WITH THE LIFESTREAM COVERED STENT. THE BRIDGING STENT WAS SIZED ACCORDING TO THE DIAMETER OF THE TARGET VESSEL (NO OVERSIZING) AND THE LENGTH FROM THE FENESTRATION/BRANCH TO WITHIN THE TARGET VESSEL TO OBTAIN A MINIMUM 15-MM DISTAL LANDING ZONE. UNFRACTIONED HEPARIN WAS ADMINISTERED INTRAVENOUSLY BEFORE AND DURING THE PROCEDURE TO MAINTAIN AN ACTIVATED CLOTTING TIME >250 SECONDS. AFTER MAIN GRAFT DEPLOYMENT THE LIFESTREAMS WERE ADVANCED THROUGH A COMPATIBLE FLEXOR SHEATH (COOK MEDICAL) AND DEPLOYED IN THE INTENDED LOCATION EITHER PROTRUDING 5 TO 10 MM WITHIN THE MAIN GRAFT IN FENESTRATED DESIGNS OR OVERLAPPING INTO THE GARGET BRANCH (18-21 MM). PROXIMAL STENT FLARING WAS PERFORMED IN ALL FENESTRATIONS WITH A 10X20 MM NONCOMPLIANT BALLOON (ARMADA 35; ABBOTT VASCULAR, SANTA CLARA, CA, USA). IN BRANCHED CASES, PROXIMAL DILATION WAS PERFORMED ONLY IF THERE WAS A DIAMETER MISMATCH BETWEEN THE COVERED STENT AND THE BRANCH. IN THESE INSTANCES, A 6- OR 8-MM NON-COMPLIANT ARMADA 35 BALLOON WAS USED. PATIENTS WERE DISCHARGED ON DOUBLE ANTIPLATELET THERAPY WITH ASPIRIN AND AN ADENOSINE DIPHOSPHATE RECEPTOR ANTAGONIST FOR THE FIRST YEAR. FIVE PATIENTS HAD TYPE IIIC ENDOLEAKS. THE PATIENT HAD TYPE IIIC PERIFENESTRATION ENDOLEAK SECONDARY TO INADEQUATE SEALING OF THE LIFESTREAM STENT-GRAFT. THE TARGET VESSEL WITH ENDOLEAK HAD NOT RECEIVED PREVIOUS STENTING. THE PATIENT RECEIVED CT SCAN AT 2 MONTHS WHICH CONFIRMED PERSISTENCE OF THE ENDOLEAK. THE PATIENT UNDERWENT A SECONDARY ENDOVASCULAR REINTERVENTION UNDER LOCAL ANAESTHESIA. A 10X20 MM BALLOON WAS INFLATED AT THE LEVEL OF FENESTRATION WHILE AORTOGRAPHY WAS PERFORMED FROM THE CONTRALATERAL GROIN TO CONFIRM THE TYPE IIIC ENDOLEAK. THE TYPE IIIC ENDOLEAK WAS SEALED WITH PROXIMAL RELINING USING A BARE BALLOON-EXPANDABLE STENT AT THE PERI-FENESTRATION TRANSITION AREA. THE ENDOLEAK WAS COMPLETELY RESOLVED AT 6 AND 12 MONTHS FROM THE SECONDARY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437989 | UNKNOWN | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM A. COOK AUSTRALIA, PTY LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |