UNKNOWN
Report
- Report Number
- 9680654-2023-00031
- Event Type
- Injury
- Date Received
- June 1, 2023
- Report Date
- July 21, 2023
- Manufacturer
- WILLIAM A. COOK AUSTRALIA, PTY LTD
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 501
Narratives
NO PART OF THE DEVICES WAS RETURNED FOR EVALUATION. NO IMAGING WAS RECEIVED TO ASSIST THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT AFTER THREE UNSUCCESSFUL REQUESTS NO FURTHER INFORMATION WAS RECEIVED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE MEDICAL DIRECTOR IN ORDER TO PROVIDE A CLINICAL ASSESSMENT, WHICH STATED THE FOLLOWING: ¿WE HAVE NO INFORMATION AS TO WHEN THE GRAFT BECAME INFECTED, AND/OR WHAT WAS THE SOURCE OF THE INFECTION. IF THE GRAFT INFECTION OCCURRED SOON AFTER IMPLANT (I.E. ALMOST ALWAYS WITHIN 14 DAYS, OCCASIONALLY OUT TO 30 DAYS) THEN IT MAY HAVE BEEN DUE TO CONTAMINATION DURING THE PROCEDURE, FAILURE OF STERILIZATION, PROCEDURAL MISHANDLING AND BREAKDOWN OF STERILE TECHNIQUE, ETC ETC. BUT IF THE INFECTION OCCURRED LATER THAN THAT, AND IF THERE WERE CLINICAL SIGNS OF INFECTION ELSEWHERE (OR IF THE PATIENT HAD HAD DENTAL TREATMENT, FOR EXAMPLE), THEN INFECTION OF THE GRAFT WOULD BE CLASSED AS SECONDARY INFECTION. THIS WOULD BE SIMILAR TO, SAY, AN ARTIFICIAL HEART VALVE, OR OTHER IMPLANTED DEVICE (EG PACEMAKER, JOINT REPLACEMENT) GETTING INFECTED JUST BY BEING IN THE BODY. IT¿S NOT ANY TYPE OF FAILURE OF THE DEVICE ¿ THE INFECTION OF THE DEVICE IS PURELY PASSIVE". REVIEW OF DEVICE HISTORY RECORDS WAS NOT COMPLETED AS MANUFACTURING RECORDS REVIEW COULD NOT BE CONDUCTED DUE TO THE LOT NUMBERS NOT BEING KNOWN. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) LIKELY SUPPLIED WITH THE DEVICE FOR GENERAL INFORMATION FOUND IT STATES: 11. POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND MAY REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO: - ANEURYSM ENLARGEMENT - DEATH - INFECTION OF THE ANEURYSM, DISSECTION, DEVICE OR ACCESS SITE, INCLUDING ABSCESS FORMATION, TRANSIENT FEVER, AND PAIN 16. IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP 16.1 GENERAL THE LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES REGULAR, LIFELONG FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS, OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADDITIONAL FOLLOW-UP. FROM THE INFORMATION RECEIVED, A DEFINITIVE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE RECEIVED AT ANY TIME IN THE FUTURE THE INVESTIGATION MAY BE UPDATED, AND AN ADDITIONAL REPORT MAY BE SUPPLIED.
LITERATURE ARTICLE: THE JOURNAL OF CARDIOVASCULAR SURGERY 2020 OCTOBER;61(5):596-603. DOI: 10.23736/S0021-9509.19.11052-X.
RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT ELECTIVE ENDOVASCULAR REPAIR (EVAR) FOR TREATMENT OF AAA FROM 1ST JANUARY 2008 TO 31ST DECEMBER 2017 IDENTIFIED FROM THE NATIONAL VASCULAR REGISTRY (NVR¿. DAWKINS, C., ET AL., ANAEROBIC THRESHOLD AS AN INDEPENDENT PREDICTOR OF MIDTERM SURVIVAL FOLLOWING ELECTIVE ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM. 2020. FOUR HUNDRED AND THIRTY PATIENTS UNDERWENT ELECTIVE EVAR FOR REPAIR OF AAA OF WHOM 389 (90.5%) WERE MEN AND 41 (9.5%) WERE WOMEN. THE MEDIAN AGE OF PATIENTS WAS 76 YEARS (RANGE: 53-91). THE MEDIAN AAA DIAMETER AT THE TIME OF REPAIR WAS 61 MM (RANGE: 45-115). IN ADDITION TO THE STUDY POPULATION, BETWEEN JANUARY 1ST, 2008 AND DECEMBER 31ST, 2017, 238 PATIENTS (216 MEN, 90.8%, 22 WOMEN, 9.2%) WITH A MEAN AGE OF 69.71±7.42 YEARS UNDERWENT ELECTIVE OPEN REPAIR OF AAA. PERIPROCEDURAL 30- DAY MORTALITY OF THESE PATIENTS WAS 1.68% (FOUR PATIENTS). INTER-OBSERVER AGREEMENT FOR CLASSIFICATION OF AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE CONSERVATIVE IFU FOR A STANDARD ENDOVASCULAR DEVICE WAS EXCELLENT (=0.83). A SIMILARLY GOOD INTER-OBSERVER CORRELATION WAS OBSERVED IN CLASSIFYING AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE LIBERAL IFU FOR STANDARD EVAR, (=0.79). THREE HUNDRED AND THIRTY-SIX PATIENTS (78.1%) HAD AORTIC ANATOMY WHICH FULFILLED A CONSERVATIVE IFU FOR STANDARD EVAR, 42 (9.8%) FULFILLED A LIBERAL INTERPRETATION OF IFU FOR EVAR AND 52 (12.1%) DID NOT MEET THE IFU FOR STANDARD INFRA RENAL EVAR. A VARIETY OF ENDOVASCULAR DEVICES WERE USED TO TREAT THESE ABDOMINAL AORTIC ANEURYSMS. EACH CASE WAS PLANNED TO MATCH THE IFU OF THE DEVICE USED. OF THE 430 PATIENTS TREATED, 374 UNDERWENT INFRA-RENAL EVAR (N.=371) OR EVAS (N.=3) AND 56 UNDERWENT COMPLEX EVAR TO EXTEND THE SEAL ZONE ABOVE THE RENAL ARTERIES (FENESTRATED EVAR OR BRANCHED STENT GRAFTS). MEDIAN DURATION OF RADIOLOGICAL FOLLOW-UP WAS 1630 DAYS (RANGE: 356-3892 DAYS). EACH PATIENT UNDERWENT A MEDIAN OF 5 (RANGE: 1-12) RADIOLOGICAL FOLLOW-UP CYCLES. THE INCIDENCE OF TYPE I ENDOLEAK AND STENT GRAFT MIGRATION DURING THE FOLLOW-UP PERIOD WAS 22 (5%) AND 13 (3%), RESPECTIVELY. IN FOUR PATIENTS, TYPE I ENDOLEAKS HAD OCCURRED DUE TO DEVICE MIGRATION; IN ADDITION, SIX GRAFT LIMBS AND TWO GRAFT BODIES HAD THROMBOSED. ONE HUNDRED AND TWENTY PATIENTS (28%) DEVELOPED TYPE II ENDOLEAKS. IN 49 PATIENTS (11.4%), THE AORTIC SAC CONTINUED TO EXPAND BY A MEDIAN OF 4 MM (2- 31 MM), WHILST IN 24 PATIENTS (5.58%) AAA SAC GROW BY IN EXCESS OF 5-MM FREEDOM FROM AAA RUPTURE AT 5 YEARS WAS 98.1% (STANDARD EVAR: 97.8%, COMPLEX EVAR: 98.2%). ONE GRAFT WAS EXPLANTED DUE TO INFECTION. THE CUMULATIVE RE-INTERVENTION RATE OVER THE DURATION OF FOLLOW-UP WAS 3.45% PER PERSON-YEARS, WHILST 5-YEAR RE-INTERVENTION FREE SURVIVAL WAS 84.3%. A TOTAL OF SIXTY-ONE RE-INTERVENTIONS WERE PERFORMED IN 59 PATIENTS (STANDARD EVAR: N.=52, COMPLEX EVAR: N.=7). NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN SURVIVAL, FREEDOM FROM RUPTURE OR RE-INTERVENTION BETWEEN PATIENTS WHO UNDERWENT STANDARD EVAR AND THOSE WHO UNDERWENT COMPLEX EVAR. USE OF COOK MANUFACTURED DEVICES: ZENITH FLEX COOK MEDICAL EUROPE X 123 (28.60%) ALPHA COOK MEDICAL EUROPE X 7 (1.63%) ZENITH T BRANCH STENT¿ (COMPLEX) COOK MEDICAL EUROPE X 2 (0.47%) ZENITH FENESTRATED STENT¿ (COMPLEX) COOK MEDICAL AUSTRALIA X 51 (11.86%) A TOTAL OF 183 COOK MEDICAL DEVICES WERE IMPLANTED. (42.657% OF ALL DEVICES USED). 51 OF THOSE DEVICES WERE MANUFACTURED BY WCA. OTHER MANUFACTURERS DEVICES: EXCLUDER¿ GORE® X 168 (39.07%) ENDURANT II¿ MEDTRONIC® X 47 (10.93%) TALENT¿ MEDTRONIC® X 6 (1.40%) AORFIX¿ LOMBARD® MEDICAL X 12 (2.79%) ANACONDA¿ VASCUTEK® X 6 (1.40%) OVATION® ENDOLOGIX® X 1 (0.23%) NELLIX ® ENDOLOGIX® X 3 (0.70%) ANACONDA¿ FENESTRATED STENT (COMPLEX) VASCUTEK® X 2 (0.70%) ENDURANT II¿ CHIMNEY CONFIGURATION (COMPLEX) MEDTRONIC® X 1 (0.23%) A TOTAL OF 246 DEVICES MANUFACTURED BY OTHER COMPANIES WERE IMPLANTED. 57.343% OF ALL DEVICES USED. THIS (B)(4) : INFECTED GRAFT REQUIRING DEVICE EXPLANATION AND OPEN REPAIR IN 1 PATIENT (1.75%) AN ADDITIONAL PATIENT REQUIRED DEVICE EXPLANT AND OPEN REPAIR DUE TO ENDOTENSION (SAC EXPANSION). NO ALLEGED DEVICE DEFICIENCY WAS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. [ONE HUNDRED AND TWENTY PATIENTS (28%) DEVELOPED TYPE II ENDOLEAKS. IN 49 PATIENTS (11.4%), THE AORTIC SAC CONTINUED TO EXPAND BY A MEDIAN OF 4 MM (2- 31 MM), WHILST IN 24 PATIENTS (5.58%) AAA SAC EXPANDED MORE THAN 5-MM].
RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT ELECTIVE ENDOVASCULAR REPAIR (EVAR) FOR TREATMENT OF AAA FROM (B)(6) 2008 TO (B)(6) 2017 IDENTIFIED FROM THE NATIONAL VASCULAR REGISTRY (NVR¿ DAWKINS, C., ET AL., ANAEROBIC THRESHOLD AS AN INDEPENDENT PREDICTOR OF MIDTERM SURVIVAL FOLLOWING ELECTIVE ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM. 2020. FOUR HUNDRED AND THIRTY PATIENTS UNDERWENT ELECTIVE EVAR FOR REPAIR OF AAA OF WHOM 389 (90.5%) WERE MEN AND 41 (9.5%) WERE WOMEN. THE MEDIAN AGE OF PATIENTS WAS 76 YEARS (RANGE: 53-91). THE MEDIAN AAA DIAMETER AT THE TIME OF REPAIR WAS 61 MM (RANGE: 45-115). IN ADDITION TO THE STUDY POPULATION, BETWEEN (B)(6) 2008 AND (B)(6) 2017, 238 PATIENTS (216 MEN, 90.8%, 22 WOMEN, 9.2%) WITH A MEAN AGE OF 69.71±7.42 YEARS UNDERWENT ELECTIVE OPEN REPAIR OF AAA. PERIPROCEDURAL 30- DAY MORTALITY OF THESE PATIENTS WAS 1.68% (FOUR PATIENTS). INTER-OBSERVER AGREEMENT FOR CLASSIFICATION OF AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE CONSERVATIVE IFU FOR A STANDARD ENDOVASCULAR DEVICE WAS EXCELLENT (=0.83). A SIMILARLY GOOD INTER-OBSERVER CORRELATION WAS OBSERVED IN CLASSIFYING AAA MORPHOLOGY AS BEING WITHIN (OR OUTSIDE) THE LIBERAL IFU FOR STANDARD EVAR, (=0.79). THREE HUNDRED AND THIRTY-SIX PATIENTS (78.1%) HAD AORTIC ANATOMY WHICH FULFILLED A CONSERVATIVE IFU FOR STANDARD EVAR, 42 (9.8%) FULFILLED A LIBERAL INTERPRETATION OF IFU FOR EVAR AND 52 (12.1%) DID NOT MEET THE IFU FOR STANDARD INFRA RENAL EVAR. A VARIETY OF ENDOVASCULAR DEVICES WERE USED TO TREAT THESE ABDOMINAL AORTIC ANEURYSMS. EACH CASE WAS PLANNED TO MATCH THE IFU OF THE DEVICE USED. OF THE 430 PATIENTS TREATED, 374 UNDERWENT INFRA-RENAL EVAR (N.=371) OR EVAS (N.=3) AND 56 UNDERWENT COMPLEX EVAR TO EXTEND THE SEAL ZONE ABOVE THE RENAL ARTERIES (FENESTRATED EVAR OR BRANCHED STENT GRAFTS). MEDIAN DURATION OF RADIOLOGICAL FOLLOW-UP WAS 1630 DAYS (RANGE: 356-3892 DAYS). EACH PATIENT UNDERWENT A MEDIAN OF 5 (RANGE: 1-12) RADIOLOGICAL FOLLOW-UP CYCLES. THE INCIDENCE OF TYPE I ENDOLEAK AND STENT GRAFT MIGRATION DURING THE FOLLOW-UP PERIOD WAS 22 (5%) AND 13 (3%), RESPECTIVELY. IN FOUR PATIENTS, TYPE I ENDOLEAKS HAD OCCURRED DUE TO DEVICE MIGRATION; IN ADDITION, SIX GRAFT LIMBS AND TWO GRAFT BODIES HAD THROMBOSED. ONE HUNDRED AND TWENTY PATIENTS (28%) DEVELOPED TYPE II ENDOLEAKS. IN 49 PATIENTS (11.4%), THE AORTIC SAC CONTINUED TO EXPAND BY A MEDIAN OF 4 MM (2- 31 MM), WHILST IN 24 PATIENTS (5.58%) AAA SAC GROW BY IN EXCESS OF 5-MM FREEDOM FROM AAA RUPTURE AT 5 YEARS WAS 98.1% (STANDARD EVAR: 97.8%, COMPLEX EVAR: 98.2%). ONE GRAFT WAS EXPLANTED DUE TO INFECTION. THE CUMULATIVE RE-INTERVENTION RATE OVER THE DURATION OF FOLLOW-UP WAS 3.45% PER PERSON-YEARS, WHILST 5-YEAR RE-INTERVENTION FREE SURVIVAL WAS 84.3%. A TOTAL OF SIXTY-ONE RE-INTERVENTIONS WERE PERFORMED IN 59 PATIENTS (STANDARD EVAR: N.=52, COMPLEX EVAR: N.=7). NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN SURVIVAL, FREEDOM FROM RUPTURE OR RE-INTERVENTION BETWEEN PATIENTS WHO UNDERWENT STANDARD EVAR AND THOSE WHO UNDERWENT COMPLEX EVAR. USE OF COOK MANUFACTURED DEVICES: ZENITH FLEX COOK MEDICAL EUROPE X 123 (28.60%), ALPHA COOK MEDICAL EUROPE X 7 (1.63%), ZENITH T BRANCH STENT¿ (COMPLEX) COOK MEDICAL EUROPE X 2 (0.47%) , ZENITH FENESTRATED STENT¿ (COMPLEX) COOK MEDICAL AUSTRALIA X 51 (11.86%). A TOTAL OF 183 COOK MEDICAL DEVICES WERE IMPLANTED. (42.657% OF ALL DEVICES USED). 51 OF THOSE DEVICES WERE MANUFACTURED BY WCA. OTHER MANUFACTURERS DEVICES: EXCLUDER¿ GORE® X 168 (39.07%) , ENDURANT II¿ MEDTRONIC® X 47 (10.93%) , TALENT¿ MEDTRONIC® X 6 (1.40%) , AORFIX¿ LOMBARD® MEDICAL X 12 (2.79%), ANACONDA¿ VASCUTEK® X 6 (1.40%) , OVATION® ENDOLOGIX® X 1 (0.23%) , NELLIX ® ENDOLOGIX® X 3 (0.70%), ANACONDA¿ FENESTRATED STENT (COMPLEX) VASCUTEK® X 2 (0.70%) , ENDURANT II¿ CHIMNEY CONFIGURATION (COMPLEX) MEDTRONIC® X 1 (0.23%). A TOTAL OF 246 DEVICES MANUFACTURED BY OTHER COMPANIES WERE IMPLANTED. 57.343% OF ALL DEVICES USED. THIS PR395939: INFECTED GRAFT REQUIRING DEVICE EXPLANATION AND OPEN REPAIR IN 1 PATIENT (1.75%) . AN ADDITIONAL PATIENT REQUIRED DEVICE EXPLANT AND OPEN REPAIR DUE TO ENDOTENSION (SAC EXPANSION). NO ALLEGED DEVICE DEFICIENCY WAS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. [ONE HUNDRED AND TWENTY PATIENTS (28%) DEVELOPED TYPE II ENDOLEAKS. IN 49 PATIENTS (11.4%), THE AORTIC SAC CONTINUED TO EXPAND BY A MEDIAN OF 4 MM (2- 31 MM), WHILST IN 24 PATIENTS (5.58%) AAA SAC EXPANDED MORE THAN 5-MM].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1131318 | UNKNOWN | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM A. COOK AUSTRALIA, PTY LTD | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |