UNKNOWN
Report
- Report Number
- 1820334-2018-01970
- Event Type
- Injury
- Date Received
- July 16, 2018
- Report Date
- September 14, 2018
- Manufacturer
- COOK INC
- Product Code
- MIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER
Narratives
METHOD CODES: DEVICE NOT RETURNED (4114). INVESTIGATION ¿ EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. WITHOUT THE COMPLAINT DEVICE, A DEVICE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF IMAGES PROVIDED IN THE ARTICLE, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE COMPLAINT DEVICE LOT NUMBER WAS NOT PROVIDED. IMAGE REVIEW WAS PERFORMED BASED ON THE IMAGES PROVIDED IN THE JOURNAL ARTICLE. PER THE IMAGE REVIEW, THE AAA WAS DETERMINED TO BE ANATOMICALLY SUITABLE FOR ENDOVASCULAR REPAIR. THE MAIN BODY OF THE GRAFT WAS RELEASED FROM THE IPSILATERAL DEPLOYMENT SYSTEM BY PULLING THE SECOND TRIP WIRE. THIS IS ASSUMED TO MEAN THE IPSILATERAL LIMB WAS FULLY DEPLOYED AND RELEASED PRIOR TO CANNULATION OF THE CONTRALATERAL LIMB AND PLACEMENT OF THE CONTRALATERAL LEG. THE IMAGE PROVIDED SHOWS, THE MAIN BODY GRAFT MIGRATED PROXIMALLY BY AT LEAST 1 CM AND THE MAIN BODY GRAFT NOW COVERING AND OCCLUDING BILATERAL RENAL ARTERIES. THE AUTHOR SUGGESTS THE ADVANCEMENT OF THE INTRODUCER INTO THE MAIN BODY COULD PUSH THE GRAFT PROXIMALLY IF THE INTRODUCER GETS CAUGHT BETWEEN THE STENT STRUTS OF THE IPSILATERAL LIMB, ESPECIALLY IF THERE IS ANGULATION OR NARROWING OF THE LIMB. THIS IS THEN DEEMED UNLIKELY SINCE, THIS OCCURRED AFTER THE INTRODUCER WAS ALREADY ADVANCED INTO THE MAIN BODY GRAFT, SO THE INTRODUCER DID NOT CAUSE THE MIGRATION BY GETTING CAUGHT IN THE STENT STRUTS OF THE IPSILATERAL LIMB. THE OTHER EXPLANATION OFFERED IS GRAFT UNDERSIZING, BUT THIS IS ALSO DISCOUNTED AS THE AUTHOR REPORTS A 26MM DIAMETER GRAFT WAS APPROPRIATELY CHOSEN FOR A 22MM AORTIC NECK DIAMETER. THE AUTHOR FINALLY NOTES THE POTENTIAL RISK OF PULLING DOWN ON A GRAFT THAT HAS BARBED SUPRARENAL FIXATION STENTS, INCLUDING INTIMAL INJURY AND AORTIC TRANSECTION. THE AUTHOR DID NOT EXPERIENCE ANY DIFFICULTY IN PULLING THIS GRAFT DOWN AND NOTED NO IMMEDIATE COMPLICATIONS. FURTHER, CTA FOLLOW-UP DID NOT SHOW ANY SIGNS OF AORTIC WALL INJURY. THE ONLY NOTABLE DISCREPANCY REPORTED IN THIS CASE IS THE ORDER OF DEPLOYMENT. THE MAIN BODY DEVICE IS COMPLETELY DEPLOYED AND RELEASED FROM THE IPSILATERAL LIMB PRIOR TO CANNULATION OF THE CONTRALATERAL LIMB AND DEPLOYMENT OF THE CONTRALATERAL LEG. DEPLOYING THE CONTRALATERAL LEG HELPS STABILIZE THE MAIN BODY GRAFT PRIOR TO RELEASING THE IPSILATERAL LIMB AND RETRIEVING THE TOP CAP. THE INSTRUCTIONS FOR USE (IFU) FOR THIS DEVICE INSTRUCTS DEPLOYMENT OF THE CONTRALATERAL LEG PRIOR TO DEPLOYMENT AND RELEASE OF THE IPSILATERAL LIMB. IN THIS CASE, WITHOUT THE GRAFT STABILIZED BY SECURING THE CONTRALATERAL LEG FIRST, THE ADVANCEMENT OF THE INTRODUCER (DILATOR) COULD HAVE PUSHED AGAINST THE WALL OF THE MAIN BODY GRAFT (NOT THE IPSILATERAL LIMB), CAUSING IT TO MIGRATE PROXIMALLY. THE SUPRARENAL STENT FIXATION, BECAUSE OF THE ANGLE OF THE BARBS, PREVENTS DISTAL MIGRATION BUT WOULD NOT NECESSARILY PREVENT PROXIMAL MIGRATION IF THE GRAFT IS PUSHED UPWARDS IMMEDIATELY AFTER IMPLANTATION. PER THE IFU, INSTRUCTIONS FOR DOCKING OF TOP CAP: LOOSEN THE PIN VISE. SECURE SHEATH AND INNER CANNULA TO AVOID ANY MOVEMENT OF THESE COMPONENTS. ADVANCE THE GRAY POSITIONER OVER THE INNER CANNULA UNTIL IT DOCKS WITH THE TOP CAP. NOTE: IF RESISTANCE OCCURS, SLIGHTLY ROTATE GRAY POSITIONER AND CONTINUE TO GENTLY ADVANCE. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE AND THE IMAGE REVIEW FINDINGS, THE LIKELY CAUSE FOR THE DEPLOYMENT DIFFICULTY AND PROXIMAL MIGRATION OF THE MAIN BODY DEVICE IS FAILURE TO FOLLOW INSTRUCTIONS DUE TO THE DISCREPANCY IN THE ORDER OF DEPLOYMENT. IN THIS CASE, WITHOUT THE GRAFT STABILIZED BY SECURING THE CONTRALATERAL LEG FIRST, THE ADVANCEMENT OF THE INTRODUCER (DILATOR) COULD HAVE PUSHED AGAINST THE WALL OF THE MAIN BODY GRAFT (NOT THE IPSILATERAL LIMB), CAUSING IT TO MIGRATE PROXIMALLY. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED A CHANGE IS NOT REQUIRED, THUS NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
CONCOMITANT PRODUCTS: Z-TRAK¿ INTRODUCTION SYSTEM (COOK MEDICAL); AXIOM ARTIS DTA; SIEMENS MEDICAL SOLUTIONS, MALVERN, PA, USA; ATLAS BALLOON DILATION CATHETER; BARD PERIPHERAL VASCULAR, TEMPE, AZ, USA; 4-FR DIAGNOSTIC CATHETER (SIM 1; CORDIS, MIAMI, FL, USA); 260-CM HYDROPHILIC 0.035' GUIDEWIRE (TERUMO RADIOFOCUS®; TERUMO EUROPE, LEUVEN, BELGIUM); 12¿20-MM ENDOVASCULAR FOREIGN BODY RETRIEVAL SYSTEM (EN SNARE®; MERIT MEDICAL, SOUTH JORDAN, UT, USA); 32-MM BALLOON DILATION CATHETER (CODA® BALLOON CATHETER; COOK INC., BLOOMINGTON, IN, USA). (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. (B)(4).
THE FOLLOWING EVENT WAS REPORTED IN JOURNAL ARTICLE, FIRST APPLICATION OF THE ¿LASSO TECHNIQUE¿ ON AN ENDOGRAFT WITH SUPRARENAL FIXATION STENT (VASCULAR, VOL. 21 NO. 3, PP. 177¿181, 2013), STAVROS SPILIOPOULOS, KEVIN MANI, TARUN SABHARWAL, MILTIADIS KROKIDIS AND PANAGIOTIS GKOUTZIOS. THE PATIENT WAS NOT OPTIMAL FOR EMERGENCY OPEN REPAIR DUE TO SEVERE SEPSIS AND HOSTILE ABDOMEN DUE TO A PREVIOUS CYSTECTOMY FOR CANCER WITH ILEAL CONDUIT AND ILEOSTOMY AS WELL AS NEOADJUVANT CHEMOTHERAPY. AS THE ANEURYSM WAS SUITABLE FOR ENDOVASCULAR REPAIR AS DEMONSTRATED BY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA), HE WAS OFFERED PRIMARY EVAR IN THE ACUTE SETTING. THE ENDOVASCULAR PROCEDURE WOULD BE USED AS A BRIDGE TO OPEN REPAIR OF THE INFECTED ANEURYSM. AN EMERGENCY EVAR USING A DEVICE WITH SUPRARENAL FIXATION AND ANCHORING BARBS (UNKNOWN ZENITH FLEX® AAA ENDOVASCULAR GRAFT) WAS PERFORMED IN THE ANGIOGRAPHY SUITE, USING A FULLY DIGITAL IMAGING UNIT EQUIPPED WITH FLAT PANEL DETECTOR TECHNOLOGY. THE PROCEDURE WAS INITIALLY DONE UNDER LOCAL ANESTHESIA BUT WAS CONVERTED TO GENERAL ANESTHESIA DURING THE PROCEDURE. SURGICAL ARTERIOTOMIES OF BOTH COMMON FEMORAL ARTERIES WERE USED FOR ACCESS. THE PATIENT WAS MAINTAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE. THE GRAFT WAS ADVANCED INTO THE AORTA AT THE LEVEL OF THE RENAL ARTERIES. ITS DELIVERY DEVICE HAS A 22-FR DIAMETER INTRODUCER SHEATH. A DIGITAL SUBTRACTED AORTOGRAM IDENTIFIED THE RENAL ARTERIES. THE INITIAL PHASE OF DEVICE DEPLOYMENT, WHICH ENABLES THE REPOSITIONING OF THE GRAFT, WAS PERFORMED USING DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE POSITION OF THE COVERED PART OF THE DEVICE WAS CLEARLY BELOW THE ORIGIN OF THE LOWER LEFT RENAL ARTERY AND THE MAIN BODY OF THE GRAFT WAS RELEASED FROM THE IPSILATERAL DEPLOYMENT SYSTEM BY PULLING THE SECOND TRIP WIRE. THE NEXT STEP INCLUDED THE ADVANCEMENT OF THE INTRODUCER AND DOCKING OF THE TOP CAP NECESSARY FOR THE RETRIEVAL OF THE MAIN BODY DELIVERY SYSTEM. DURING THIS PHASE AND WHILE THE INTRODUCER HAD ALREADY PASSED INTO THE COVERED PART OF THE MAIN BODY, THE GRAFT WAS PUSHED AND MIGRATED 1 CM PROXIMALLY, ABOVE THE RENAL ARTERIES. IMAGING CONFIRMED THE DEVICE MIGRATION. THE INTRODUCER OF THE DEVICE MAIN BODY WAS REMOVED AND THE 22-FR SHEATH WAS LEFT IN THE RIGHT COMMON ILIAC ARTERY. ATTEMPTS TO PULL DOWN THE MAIN BODY USING TWO 12 MM× 40 MM BALLOONS FROM OTHER MANUFACTURERS WERE UNSUCCESSFUL. AT THAT POINT, THE AUTHORS DECIDED TO APPLY THE ¿LASSO TECHNIQUE¿. A 4-FR DIAGNOSTIC CATHETER FROM ANOTHER MANUFACTURER WAS INSERTED FROM THE RIGHT SIDE, FORMED IN THE AORTA AND PULLED DOWN IN THE MAIN BODY OF THE GRAFT, ENGAGING THE CONTRALATERAL LIMB OF THE GRAFT. A 260-CM HYDROPHILIC GUIDE WIRE FROM ANOTHER MANUFACTURER WAS ADVANCED IN THE CATHETER AND OUT OF ITS TIP AND THE CONTRALATERAL OPEN END LIMB OF THE MAIN BODY GRAFT. THE DISTAL END OF THE GUIDE WIRE WAS PROTRUDING IN THE ABDOMINAL AORTA, JUST BELOW THE CONTRALATERAL LIMB OF THE MAIN BODY GRAFT. A 12¿20-MM ENDOVASCULAR FOREIGN BODY RETRIEVAL SYSTEM FROM ANOTHER MANUFACTURER WAS INSERTED FROM THE LEFT 7-FR ARTERIAL SHEATH AND THE DISTAL END OF THE GUIDE WIRE WAS SNARED AND PULLED OUT OF THE SHEATH. THE GUIDE WIRE WAS NOW OUT THROUGH AND THROUGH FROM BOTH FEMORAL ARTERIES. SUCCESSIVELY, THE OPERATOR USING BOTH ENDS OF THE GUIDE WIRE, PULLED THE MAIN BODY DOWN. FINAL DSA FOLLOWING THE ADJUSTMENT MANEUVER CONFIRMED THE CORRECT POSITION OF THE MAIN BODY AND THE PATENCY OF BOTH RENAL ARTERIES. THE ANEURYSM WAS SUCCESSFULLY EXCLUDED FROM CIRCULATION AND NO ENDOLEAK, CONTRAST EXTRAVASATION, AORTIC DISSECTION OR ANY OTHER COMPLICATION WAS NOTED. FOLLOWING THE PROCEDURE, THE ABSCESS WAS DRAINED PERCUTANEOUSLY, THE PATIENT WAS COVERED WITH INTRAVENOUS ANTIBIOTICS AND WAS DISCHARGED FROM THE HOSPITAL AFTER 14 DAYS. HOWEVER, AS RECURRENT SEPSIS AND REMAINING SIGNS OF PERIAORTIC INFECTION PERSISTED TWO MONTHS FOLLOWING THE EMERGENCY EVAR, AN OPEN EXTRA-ANATOMIC AXILLO-BIFEMORAL BYPASS WAS PERFORMED, THE ENDOGRAFT WAS SUCCESSFULLY REMOVED AND THE INFECTION WAS DRAINED. THE PATIENT IS ALIVE AFTER EIGHT MONTHS FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532568 | UNKNOWN | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |