ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS
Report
- Report Number
- 3002808486-2020-01129
- Event Type
- Death
- Date Received
- December 9, 2020
- Date of Event
- November 27, 2020
- Report Date
- November 30, 2021
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 10827002448848
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER REF#: (B)(4). INVESTIGATION IS STILL IN PROGRESS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
MANUFACTURERS REF # (B)(4). SUMMERY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2020, A MALE PATIENT IN HIS 80S WITH ARTERIOSCLEROSIS OBLITERANS (ASO), ABDOMINAL AORTIC ANEURYSM (AAA) AND THORACIC AORTIC ANEURYSM (TAA) UNDERWENT TEVAR BY LEFT COMMON FEMORAL ARTERY APPROACH. THE RIGHT ILIAC ARTERY WAS TOTALLY OCCLUDED DUE TO ASO, SO FEMORAL-FEMORAL BYPASS HAD ALREADY BEEN PERFORMED. SINCE THERE WAS STENOSIS WITH SEVERE CALCIFICATION IN THE LEFT ILIAC ARTERY, TEVAR WAS CONDUCTED AFTER THE ACCESS ROUTE WAS SECURED WITH THE ENDO CONDUIT TECHNIQUE WITH A ENDOPROSTHESIS FROM ANOTHER MANUFACTURER. THE PHYSICIAN JUDGED THAT THE PATIENT WAS SUITABLE FOR TEVAR WITH THE ENDO CONDUIT TECHNIQUE AND HE DID NOT SELECT THE OPEN SURGERY DUE TO THE PATIENT¿S AGE. AFTER PLACING THE FIRST DEVICE (ZTA-P-36-209-W1) THE PHYSICIAN DEPLOYED THE SECOND DEVICE ZTA-D-36-142-W1 (COMPLAINT DEVICE) WITH ADJUSTING THE POSITION OF THE DISTAL PART OF THE GRAFT AT JUST ABOVE THE CELIAC ARTERY HOWEVER, THE DISTAL BARE STENT WAS INSUFFICIENTLY DEPLOYED. THEREFORE, THE PHYSICIAN ATTEMPTED TO RELEASE THE TRIGGER WIRES, FOLLOWING TROUBLE SHOOTING WRITTEN IN THE PACKAGE INSERT. HE PULLED THE BACK-END CAP OUT, THEN PULLED ALL THE TRIGGER WIRES. AFTER THAT, THE PHYSICIAN TRIED TO WITHDRAW THE WHOLE DELIVERY SYSTEM, BUT ENCOUNTERED STRONG RESISTANCE CREATED AROUND THE INSUFFICIENTLY DEPLOYED BARE STENT AND COULD NOT REMOVE THE DELIVERY SYSTEM. THEREFORE, THE PHYSICIAN PUSHED THE SHEATH UP TO THE DISTAL END OF THE GRAFT AND WHEN TRYING TO WITHDRAW THE DEVICE BY ROTATING IT, THE STENT GRAFT AND SHEATH WAS ENGAGED, WHICH WAS SUSPECTED TO BE CAUSED BY A BARB OF THE BARE STENT PENETRATING THE SHEATH. THE PHYSICIAN REPEATEDLY PUSHED UP AND PULLED BACK THE SHEATH THOUGH, THE SHEATH AND STENT GRAFT COULD NOT BE DETACHED. IN CONSIDERATION OF EFFECTS BY ISCHEMIA IN THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, AND RENAL ARTERY AND A RISK OF AORTA DAMAGE, THE PHYSICIAN DECIDED TO CHANGE THE PROCEDURE TO OPEN SURGERY. IN OPEN SURGERY THE AAA WAS TREATED BY REPLACING THE ABDOMINAL AORTA WITH AN ARTIFICIAL VESSEL(Y-GRAFT). AFTER THAT DURING THE SURGERY, BLOOD FLOW WAS BLOCKED ABOVE THE RENAL ARTERIES AND THE AORTA WAS CUT. THE USER SEPARATED THE COMPLAINT DEVICE AND REMOVED IT FROM THE PATIENT. ANOTHER ZTA-P-36-161-W1 WAS PLACED INSTEAD THROUGH THE RIGHT LIMB OF THE PREVIOUSLY PLACED Y-GRAFT BEFORE CLOSING THE ABDOMEN. BY ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN ON (B)(6) 2020; PLEURAL EFFUSION WAS BUILT UP, AND WHEN THE PHYSICIAN ATTEMPTED TO DRAIN IT, HE PUNCTURED THE ARTERY ACCIDENTALLY. THE PATIENT WAS TRANSFERRED TO THE ICU AGAIN. HOWEVER, PER THE PHYSICIAN, THIS EVENT WAS NOT RELATED TO ZENITH ALPHA THORACIC DEVICES. ON (B)(6) 2021 COOK WAS INFORMED THAT THE PATIENT DEVELOPED PNEUMONIA. THE PATIENT EXPIRED 3 MONTH AFTER TEVAR DUE TO PNEUMONIA AND PANCREATITIS. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUTSIDE OF SPECIFICATIONS. ANGIOGRAPHIC IMAGING FROM THE PROCEDURE, THREE IMAGES PHOTOGRAPHED FROM AN ANGIOGRAPHY MONITOR DATED (B)(6) 2021 AND ONE PHOTOGRAPH OF THE REMOVED GRAFT WERE PROVIDED AND REVIEWED BY AN IMAGING EXPERT. IN THE ANGIOGRAPHIC IMAGES PROVIDED THE IMAGING REVIEWER FOUND THAT THE INFERIOR END OF THE DISTAL STENT WAS SEPARATED FROM WHERE THE BOTTOM CAP THREADS ON THE DELIVERY SYSTEM BY 14MM. THE INFERIOR END OF THE DISTAL STENT WAS CONSTRAINED TO 4.2MM. PER THE IMAGING REVIEWERS IMPRESSION THE 4MM DIAMETER OF THE DISTAL BARE STENT AND THE 14MM SEPARATION BETWEEN THE DISTAL BARE STENT AND BOTTOM CAP THREADS SUGGEST THAT THE BARE STENT CONSTRAINT WAS SECONDARY TO INCOMPLETE RETRACTION OF THE BOTTOM CAP. ON THE TWO ANGIOGRAPHIC IMAGES, PHOTOGRAPHED FROM THE MONITOR, THE IMAGING REVIEWER FOUND ENTRAPMENT OF THE BARE STENT IN THE DISTAL SHEATH BY ADVANCEMENT OF THE SHEATH AGAINST INTRODUCER TIP RETRACTION, AND ON THE REMOVED DEVICE PHOTOGRAPH THE INTRODUCER TIP WAS FOUND TO BE PULLED MORE THAN HALFWAY INTO THE SHEATH. THE IMAGING REVIEWER STATES THAT IT IS MOST LIKELY THAT THE BOTTOM CAP WAS RELEASED TO ENABLE THIS BECAUSE THE BOTTOM CAP WOULD HAVE BLOCKED THE INTRODUCER TIP RETRACTION INTO THE SHEATH. ALSO, IF THE BOTTOM CAP HAD NOT RELEASED, THE MULTIPLE BARBS PENETRATING THE SHEATH VISIBLE ON THE PHOTOGRAPH WOULD HAVE BEEN REQUIRED TO PENETRATE THE BOTTOM CAP AND THEN THE SHEATH. IN ADDITION TO THE IMAGING THE DEVICE, INCLUDING THE STENT GRAFT AND INTRODUCTION SYSTEM, WERE RETURNED AND EVALUATED IN THE LABORATORY. IT WAS FOUND THAT THE DISTAL BARE STENT WAS SEPARATED FROM THE REST OF THE STENTGRAFT AND WAS LOCATED INSIDE THE TIP OF THE SHEATH. THE BARE STENT WAS UNBROKEN WITH ONE BARB ESPECIALLY PROTRUDING AND SLIGHTLY TWISTED. THE BOTTOM CAP WAS LOCATED 198.5 - 230MM FROM THE TIP INSIDE THE SHEATH AND A SCRATCH/GROOVE WAS OBSERVED ON THE INNER SIDE OF THE BOTTOM CAP, GOING FROM THE WIRE HOLE TOWARDS THE EDGE OF THE BOTTOM CAP, AWAY FROM THE GRAY POSITIONER. THE PRODUCT EVALUATION INDICATES THAT A BARB FROM THE DISTAL BARE STENT WAS CAUGHT IN THE BOTTOM CAP. ADDITIONALLY FIVE BARBS WERE PROTRUDING THE SHEATH, WHICH LIKELY OCCURRED DURING THE ATTEMPT TO FREE THE DISTAL BARE STENT FROM BOTTOM CAP. BASED ON THE PROVIDED IMAGES, INFORMATION, AND THE RETURNED PRODUCT THE EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. IT IS LIKELY THAT A BARB WAS CAUGHT IN THE BOTTOM CAP, WHICH PREVENTED FULL RELEASE OF THE DISTAL BARE STENT. IT WAS REPORTED THAT TO RESOLVE THIS THE PHYSICIAN TRIED TO WITHDRAW THE WHOLE SYSTEM AFTER RELEASING THE TRIGGER WIRES, BUT ENCOUNTERED RESISTANCE AND THEN PUSHED THE SHEATH UP TO THE DISTAL END OF THE GRAFT, THIS MIGHT HAVE CAUSED THAT THE SHEATH, BARE STENT AN DILATOR TIP WAS ENGAGED WITH SEVERAL BARBS PROTRUDING THE SHEATH. INTERNAL ACTION HAS BEEN INITIATED TO ADDRESS THE DIFFICULTY WITH RELEASING THE DISTAL END OF THE STENT GRAFT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
MANUFACTURER REF# (B)(4) INVESTIGATION IS STILL IN PROGRESS. 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.
MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: ON (B)(6) 2020, A MALE PATIENT IN HIS 80S WITH ARTERIOSCLEROSIS OBLITERANS (ASO), ABDOMINAL AORTIC ANEURYSM (AAA) AND THORACIC AORTIC ANEURYSM (TAA) UNDERWENT TEVAR BY LEFT COMMON FEMORAL ARTERY APPROACH. THE RIGHT ILIAC ARTERY WAS TOTALLY OCCLUDED DUE TO ASO, SO FEMORAL-FEMORAL BYPASS HAD ALREADY BEEN PERFORMED. SINCE THERE WAS STENOSIS WITH SEVERE CALCIFICATION IN THE LEFT ILIAC ARTERY, TEVAR WAS CONDUCTED AFTER THE ACCESS ROUTE WAS SECURED WITH THE ENDO CONDUIT TECHNIQUE WITH A ENDOPROSTHESIS FROM ANOTHER MANUFACTURER. THE PHYSICIAN JUDGED THAT THE PATIENT WAS SUITABLE FOR TEVAR WITH THE ENDO CONDUIT TECHNIQUE AND HE DID NOT SELECT THE OPEN SURGERY DUE TO THE PATIENT¿S AGE. AFTER PLACING THE FIRST DEVICE (ZTA-P-36-209-W1) THE PHYSICIAN DEPLOYED THE SECOND DEVICE ZTA-D-36-142-W1 (COMPLAINT DEVICE) WITH ADJUSTING THE POSITION OF THE DISTAL PART OF THE GRAFT AT JUST ABOVE THE CELIAC ARTERY HOWEVER, THE DISTAL BARE STENT WAS INSUFFICIENTLY DEPLOYED. THEREFORE, THE PHYSICIAN ATTEMPTED TO RELEASE THE TRIGGER WIRES, FOLLOWING TROUBLE SHOOTING WRITTEN IN THE PACKAGE INSERT. HE PULLED THE BACK-END CAP OUT, THEN PULLED ALL THE TRIGGER WIRES. AFTER THAT, THE PHYSICIAN TRIED TO WITHDRAW THE WHOLE DELIVERY SYSTEM, BUT ENCOUNTERED STRONG RESISTANCE CREATED AROUND THE INSUFFICIENTLY DEPLOYED BARE STENT AND COULD NOT REMOVE THE DELIVERY SYSTEM. THEREFORE, THE PHYSICIAN PUSHED THE SHEATH UP TO THE DISTAL END OF THE GRAFT AND WHEN TRYING TO WITHDRAW THE DEVICE BY ROTATING IT, THE STENT GRAFT AND SHEATH WAS ENGAGED, WHICH WAS SUSPECTED TO BE CAUSED BY A BARB OF THE BARE STENT PENETRATING THE SHEATH. THE PHYSICIAN REPEATEDLY PUSHED UP AND PULLED BACK THE SHEATH THOUGH, THE SHEATH AND STENT GRAFT COULD NOT BE DETACHED. IN CONSIDERATION OF EFFECTS BY ISCHEMIA IN THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, AND RENAL ARTERY AND A RISK OF AORTA DAMAGE, THE PHYSICIAN DECIDED TO CHANGE THE PROCEDURE TO OPEN SURGERY. IN OPEN SURGERY THE AAA WAS TREATED BY REPLACING THE ABDOMINAL AORTA WITH AN ARTIFICIAL VESSEL(Y-GRAFT). AFTER THAT DURING THE SURGERY, BLOOD FLOW WAS BLOCKED ABOVE THE RENAL ARTERIES AND THE AORTA WAS CUT. THE USER SEPARATED THE COMPLAINT DEVICE AND REMOVED IT FROM THE PATIENT. ANOTHER ZTA-P-36-161-W1 WAS PLACED INSTEAD THROUGH THE RIGHT LIMB OF THE PREVIOUSLY PLACED Y-GRAFT BEFORE CLOSING THE ABDOMEN. BY ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN ON (B)(6) 2020; PLEURAL EFFUSION WAS BUILT UP, AND WHEN THE PHYSICIAN ATTEMPTED TO DRAIN IT, HE PUNCTURED THE ARTERY ACCIDENTALLY. THE PATIENT WAS TRANSFERRED TO THE ICU AGAIN. HOWEVER, PER THE PHYSICIAN, THIS EVENT WAS NOT RELATED TO ZENITH ALPHA THORACIC DEVICES. ON (B)(6) 2021 COOK WAS INFORMED THAT THE PATIENT DEVELOPED PNEUMONIA. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUTSIDE OF SPECIFICATIONS. ANGIOGRAPHIC IMAGING FROM THE PROCEDURE, THREE IMAGES PHOTOGRAPHED FROM AN ANGIOGRAPHY MONITOR DATED (B)(6) 2021 AND ONE PHOTOGRAPH OF THE REMOVED GRAFT WERE PROVIDED AND REVIEWED BY AN IMAGING EXPERT. IN THE ANGIOGRAPHIC IMAGES PROVIDED THE IMAGING REVIEWER FOUND THAT THE INFERIOR END OF THE DISTAL STENT WAS SEPARATED FROM WHERE THE BOTTOM CAP THREADS ON THE DELIVERY SYSTEM BY 14MM. THE INFERIOR END OF THE DISTAL STENT WAS CONSTRAINED TO 4.2MM. PER THE IMAGING REVIEWERS IMPRESSION THE 4MM DIAMETER OF THE DISTAL BARE STENT AND THE 14MM SEPARATION BETWEEN THE DISTAL BARE STENT AND BOTTOM CAP THREADS SUGGEST THAT THE BARE STENT CONSTRAINT WAS SECONDARY TO INCOMPLETE RETRACTION OF THE BOTTOM CAP. ON THE TWO ANGIOGRAPHIC IMAGES, PHOTOGRAPHED FROM THE MONITOR, THE IMAGING REVIEWER FOUND ENTRAPMENT OF THE BARE STENT IN THE DISTAL SHEATH BY ADVANCEMENT OF THE SHEATH AGAINST INTRODUCER TIP RETRACTION, AND ON THE REMOVED DEVICE PHOTOGRAPH THE INTRODUCER TIP WAS FOUND TO BE PULLED MORE THAN HALFWAY INTO THE SHEATH. THE IMAGING REVIEWER STATES THAT IT IS MOST LIKELY THAT THE BOTTOM CAP WAS RELEASED TO ENABLE THIS BECAUSE THE BOTTOM CAP WOULD HAVE BLOCKED THE INTRODUCER TIP RETRACTION INTO THE SHEATH. ALSO, IF THE BOTTOM CAP HAD NOT RELEASED, THE MULTIPLE BARBS PENETRATING THE SHEATH VISIBLE ON THE PHOTOGRAPH WOULD HAVE BEEN REQUIRED TO PENETRATE THE BOTTOM CAP AND THEN THE SHEATH. IN ADDITION TO THE IMAGING THE DEVICE, INCLUDING THE STENT GRAFT AND INTRODUCTION SYSTEM, WERE RETURNED AND EVALUATED IN THE LABORATORY. IT WAS FOUND THAT THE DISTAL BARE STENT WAS SEPARATED FROM THE REST OF THE STENTGRAFT AND WAS LOCATED INSIDE THE TIP OF THE SHEATH. THE BARE STENT WAS UNBROKEN WITH ONE BARB ESPECIALLY PROTRUDING AND SLIGHTLY TWISTED. THE BOTTOM CAP WAS LOCATED 198.5 - 230MM FROM THE TIP INSIDE THE SHEATH AND A SCRATCH/GROOVE WAS OBSERVED ON THE INNER SIDE OF THE BOTTOM CAP, GOING FROM THE WIRE HOLE TOWARDS THE EDGE OF THE BOTTOM CAP, AWAY FROM THE GRAY POSITIONER. THE PRODUCT EVALUATION INDICATES THAT A BARB FROM THE DISTAL BARE STENT WAS CAUGHT IN THE BOTTOM CAP. ADDITIONALLY FIVE BARBS WERE PROTRUDING THE SHEATH, WHICH LIKELY OCCURRED DURING THE ATTEMPT TO FREE THE DISTAL BARE STENT FROM BOTTOM CAP. BASED ON THE PROVIDED IMAGES, INFORMATION, AND THE RETURNED PRODUCT THE EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. IT IS LIKELY THAT A BARB WAS CAUGHT IN THE BOTTOM CAP, WHICH PREVENTED FULL RELEASE OF THE DISTAL BARE STENT. IT WAS REPORTED THAT TO RESOLVE THIS THE PHYSICIAN TRIED TO WITHDRAW THE WHOLE SYSTEM AFTER RELEASING THE TRIGGER WIRES, BUT ENCOUNTERED RESISTANCE AND THEN PUSHED THE SHEATH UP TO THE DISTAL END OF THE GRAFT, THIS MIGHT HAVE CAUSED THAT THE SHEATH, BARE STENT AN DILATOR TIP WAS ENGAGED WITH SEVERAL BARBS PROTRUDING THE SHEATH. INTERNAL ACTION HAS BEEN INITIATED TO ADDRESS THE DIFFICULTY WITH RELEASING THE DISTAL END OF THE STENT GRAFT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
MANUFACTURER REF#: (B)(4). INVESTIGATION IS STILL IN PROGRESS. 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.
ADDITIONAL INFORMATION RECEIVED 07JUN2021: IT IS UNKNOWN IF AUTOPSY WAS PERFORMED OR NOT. THE CAUSE OF PLEURAL EFFUSION SEEMS TO BE THE ASPIRATION PNEUMONITIS ACCORDING TO THE VASCULAR AI MANAGER THOUGH, THE MANAGER DID NOT OBTAIN A CERTAIN OPINION FROM THE PHYSICIAN. THE PHYSICIAN ONLY TOLD THE MANAGER THAT THE PATIENT HAD DEVELOPED ASPORTATION PNEUMONITIS FIRST, THEN TOLD HIM THAT THERE WAS PLEURAL EFFUSION. THE VASCULAR AI MANAGER DID NOT RECEIVE A SPECIFIC OPINION FROM THE PHYSICIAN ABOUT THE RELATION BETWEEN THE COMPLAINT DEVICE AND DEATH. THE MANAGER THINKS THAT THE PATIENT COULD HAVE BEEN DISCHARGED FROM THE HOSPITAL IF THE REPORTED EVENT (UNABLE TO DEPLOY THE STENT GRAFT PROPERLY) HAD NOT OCCURRED. HOWEVER, ACCORDING TO THE MANAGER, THERE WAS STILL A POSSIBILITY THAT THE PATIENT WOULD HAVE DEVELOPED ASPORTATION PNEUMONITIS EVEN IF HE HAD BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED 04JUN2021: THE PATIENT EXPIRED 3 MONTHS AFTER THE PROCEDURE DUE TO PNEUMONIA AND PANCREATITIS. THE PATIENT DEVELOPED ASPIRATION PNEUMONITIS AND ALSO THE INTERCOSTAL ARTERY WAS PUNCTURED ACCIDENTALLY WHEN THE PHYSICIAN ATTEMPTED TO DRAIN PLEURAL EFFUSION AS PREVIOUSLY DESCRIBED IN DESCRIPTION OF EVENT AND PATIENT OUTCOME FIELDS. THE PHYSICIAN THINKS THAT THE PATIENT COULD NOT BEAR THE CONDITIONS DUE TO ADVANCED AGE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020: PLEURAL EFFUSION WAS BUILT UP, SO WHEN THE PHYSICIAN ATTEMPTED TO DRAIN IT, HE PUNCTURED THE ARTERY ACCIDENTALLY. THE PATIENT WAS TRANSFERRED TO THE ICU AGAIN. HOWEVER, THIS EVENT WAS NOT RELATED TO ZENITH ALPHA THORACIC DEVICES. IF ALL GOES WELL, THE PHYSICIAN EXPECTS THAT THE PATIENT WILL BE ABLE TO BE DISCHARGED FROM THE HOSPITAL BY THE END OF YEAR 2020.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
PATIENT OUTCOME: ADDITIONAL INFORMATION RECEIVED ON 15JAN2021: THE PATIENT HAS NOT BEEN ABLE TO BE DISCHARGED FROM THE HOSPITAL YET. HIS CONDITION WAS WELL LAST WEEK (WEEK ON (B)(6), BUT BECAME WORSE THIS WEEK (WEEK ON (B)(6). ADDITIONAL INFORMATION RECEIVED ON 19JAN2021: THE PATIENT DEVELOPED PNEUMONIA.
MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER 510(K)/PMA: P140016. INVESTIGATION IS STILL IN PROGRESS.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2020, A MALE PATIENT IN HIS 80S WITH ASO, AAA AND TAA UNDERWENT TEVAR BY LEFT CFA APPROACH. THE RIGHT ILIAC ARTERY WAS TOTALLY OCCLUDED DUE TO ASO, SO F-F BYPASS HAD BEEN ALREADY PERFORMED. SINCE THERE WAS STENOSIS WITH SEVERE CALCIFICATION IN THE LEFT ILIAC ARTERY, TEVAR WAS CONDUCTED AFTER THE ACCESS ROUTE WAS SECURED WITH THE ENDO CONDUIT TECHNIQUE WITH GORE'S VIAHAHN VBX (F8MM X 79MM + F10MM × 79MM). THE PHYSICIAN JUDGED THAT THE PATIENT WAS SUITABLE FOR TEVAR WITH THE ENDO CONDUIT TECHNIQUE AND HE DID NOT SELECT THE OPEN CHEST SURGERY DUE TO OLD AGE. APART FROM PERFORMING ENDO CONDUIT TECHNIQUE, THE TEVAR WAS CONDUCTED AS LABELED WITH USING A LUNDERQUIST DOUBLE CURVED WIRE GUIDE. AFTER PLACING THE FIRST DEVICE (ZTA-P-36-209-W1) IN THE DESCENDING AORTA, THE PHYSICIAN DEPLOYED THE SECOND DEVICE (COMPLAINT DEVICE: ZTA-D-36-142-W1) WITH ADJUSTING THE POSITION OF THE DISTAL PART OF THE GRAFT AT JUST ABOVE THE CELIAC ARTERY. THOUGH THE PHYSICIAN HANDLED THE DEVICE WITH FOLLOWING THE NORMAL PROCEDURE, THE DISTAL BARE STENT WAS INSUFFICIENTLY DEPLOYED. THEREFORE, HE ATTEMPTED TO RELEASE THE TRIGGER WIRES WITH FOLLOWING THE ALTERNATIVE METHOD (TROUBLE SHOOTING) WRITTEN IN THE PACKAGE INSERT. HE PULLED THE BACK-END CAP OUT, THEN PULLED ALL THE TRIGGER WIRES. AFTER THAT, THE PHYSICIAN TRIED TO WITHDRAW THE WHOLE DELIVERYSYSTEM, BUT HE ENCOUNTERED STRONG RESISTANCE CREATED AROUND THE INSUFFICIENTLY DEPLOYED BARE STENT AND HE COULD NOT REMOVE THE DELIVERY SYSTEM. THEREFORE, HE PUSHED THE SHEATH UP TO THE DISTAL END OF THE GRAFT, AND WHEN HE TRIED TO WITHDRAW IT WITH ROTATING IT, THE BARB OF THE BARE STENT PENETRATED THE SHEATH, WHICH MADE THE STENT GRAFT AND SHEATH ENGAGED. THE USER REPEATEDLY PUSHED UP AND PULLED BACK THE SHEATH THOUGH, THE SHEATH AND STENT GRAFT COULD NOT BE DETACHED. IN CONSIDERATION OF EFFECTS BY ISCHEMIA IN THE CA, SMA, AND RENAL ARTERY AND A RISK OF AORTA DAMAGE, THE PHYSICIAN DECIDED TO CHANGE THE PROCEDURE TO THE SURGERY. SINCE THE PROCEDURE WAS CHANGED TO SURGERY, ABDOMINAL AORTA REPLACEMENT WITH AN ARTIFICIAL VESSEL CALLED Y-GRAFT WAS PERFORMED FOR THE AAA. AFTER THAT DURING THE SURGERY, BLOOD FLOW WAS BLOCKED ABOVE THE RENAL ARTERIES AND THE AORTA WAS CUT. THE USER SEPARATED STENT GRAFT (COMPLAINT DEVICE: ZTA-D-36-142-W1) AND REMOVED IT FROM THE PATIENT, THEN ANOTHER STENT GRAFT (ZTA-P-36-161-W1) WAS PLACED INSTEAD THROUGH THE RIGHT LIMB OF THE PREVIOUSLY PLACED Y-GRAFT BEFORE CLOSING THE ABDOMEN. THE RIGHT LIMB OF THE Y-GRAFT WAS CLOSED AFTER PLACING ZTA-P-36-161-W1 DUE TO TOTAL OCCLUSION OF THE RIGHT ILIAC ARTERY. PATIENT OUTCOME: THE PATIENT HAS A FAVORABLE OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1442994 | ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | E3925495 | 10827002448848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Life Threatening| R |