ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

Report

Report Number: 1820334-2015-00781
Event Type: Injury
Date Received: November 23, 2015
Date of Event: August 19, 2014
Report Date: October 29, 2015
Manufacturer: COOK INC
Product Code: MIH
PMA / PMN Number: P020018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

Additional Manufacturer Narrative · 1

(B)(4). INVESTIGATION - EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE RECORD HISTORY, INSTRUCTIONS FOR USE (IFU) AND TRENDS WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: PATIENT SELECTION, TREATMENT AND FOLLOW-UP: PRE-EXISTING REGIONS OF STENOSIS/NARROWING HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G. LEG GRAFT OCCLUSION). THE POTENTIAL FOR THIS INCREASED RISK IN THESE PATIENTS MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. DILATION OF THESE REGIONS WITH A NONCOMPLIANT BALLOON AND/OR STENT PLACEMENT MAY BE NECESSARY TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT, RE-INTERVENTION SHOULD BE CONSIDERED TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. MULTIPLE LARGE, PATENT LUMBAR ARTERIES, MURAL THROMBUS AND A PATENT INFERIOR MESENTERIC ARTERY MAY ALL PREDISPOSE A PATIENT TO TYPE II ENDOLEAKS. PATIENTS WITH UNCORRECTABLE COAGULOPATHY MAY ALSO HAVE AN INCREASED RISK OF TYPE II ENDOLEAK OR BLEEDING COMPLICATIONS. IMPLANT PROCEDURE: EXCESSIVE OVERLAP 10MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. POTENTIAL ADVERSE EFFECTS: ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDO ANEURYSM. CLAUDICATION (E.G. BUTTOCK, LOWER LIMB). ROOT CAUSE COULD NOT BE DETERMINED: DUE TO LIMITED ACCESS TO THE PATIENTS MEDICAL HISTORY IT IS DIFFICULT TO ELIMINATE ANY PRE-EXISTING CONDITIONS THAT WOULD HAVE/HAVE NOT PREDISPOSE THE PATIENT TO A THROMBOEMBOLIC EVENT. BECAUSE A TYPE II ENDOLEAK WAS INITIALLY REPORTED AS BEING DETECTED DURING POST SURGERY FOLLOW-UP, THE THROMBOEMBOLIC EVENT WAS MOST LIKELY DUE TO CONDITIONS CAUSED BY THE ENDOLEAK AND NOT A DEFECTIVE DEVICE. IN ADDITION, THERE WAS NOT ENOUGH DETAILS PROVIDED RELATED TO THE IMPLANT PROCEDURE TO DETERMINE IF CERTAIN TECHNIQUES (IE EXCESSIVE OVERLAP) WERE USED BY THE PHYSICIAN THAT COULD HAVE INCREASED THE RISK OF LIMB THROMBOSIS. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

Additional Manufacturer Narrative · 1

INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. BASED ON THE AVAILABLE INFORMATION IT¿S NOT CLEAR IF THE REPORTED EVENT IS ASSOCIATED WITH PATIENT¿S PRIOR DISEASE STATE/CLINICAL CONDITION, AND/OR PHYSICIAN TECHNIQUE/PROCEDURE AND/OR THE MALFUNCTION OF THE DEVICE. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: DETAILED INSTRUCTIONS FOR USE, AND INSTRUCTIONS RELATED TO THE USE OF THE DEVICE THAT COULD CAUSE OR "CONTRIBUTE TO" THROMBOSIS AND TYPE II ENDO LEAKS: SECTION 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP: -PRE-EXISTING REGIONS OF STENOSIS/NARROWING HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT (E.G. LEG GRAFT OCCLUSION). THE POTENTIAL FOR THIS INCREASED RISK IN THESE PATIENTS MAY PRECLUDE PLACEMENT OF AN ENDOVASCULAR GRAFT. DILATION OF THESE REGIONS WITH A NONCOMPLIANT BALLOON AND/OR STENT PLACEMENT MAY BE NECESSARY TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. -FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPRX. 5MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT, RE-INTERVENTION SHOULD BE CONSIDERED TO HELP ASSURE MAINTAINED GRAFT PATENCY AND TO REDUCE THE RISK OF A THROMBOEMBOLIC EVENT. -PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. -MULTIPLE LARGE, PATENT LUMBAR ARTERIES, MURAL THROMBUS AND A PATENT INFERIOR MESENTERIC ARTERY MAY ALL PREDISPOSE A PATIENT TO TYPE II ENDOLEAKS. PATIENTS WITH UNCORRECTABLE COAGULOPATHY MAY ALSO HAVE AN INCREASED RISK OF TYPE II ENDOLEAK OR BLEEDING COMPLICATIONS. SECTION 4.5 IMPLANT PROCEDURE: -EXCESSIVE OVERLAP 10MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. SECTION 5.2 POTENTIAL ADVERSE EFFECTS: -ARTERIAL OR VENOUS THROMBOSIS AND/OR PSEUDO ANEURYSM. -CLAUDICATION (E.G. BUTTOCK, LOWER LIMB)". THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

A (B)(6) MALE PATIENT IN THE SPIRAL-Z POST-MARKET REGISTRY (11-015) EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK) ON (B)(6) 2014 (103 DAYS POST PROCEDURE) AND LOWER EXTREMITY ISCHEMIA (413 DAYS POST PROCEDURE). THE PATIENT WAS TREATED ON 05/08/2014 FOR AN AORTIC ANEURYSM. THE MAXIMUM AORTIC DIAMETER WAS 58 MM. THE PROXIMAL NECK HAD AN IRREGULAR SHAPE WITH PARTIAL PLAQUE/THROMBUS. THE BILATERAL ILIAC ARTERIES HAD MILD TORTUOSITY, NO OCCLUSIVE DISEASE, AND MILD CALCIFICATION. THE PATIENT RECEIVED A 22MM X 98MM MAIN-BODY DEVICE(ANOTHER MANUFACTURER), A 16MM X 74MM LEFT ILIAC LEG, AND A 16MM X 56MM RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER PROCEDURES WERE PERFORMED AND NO ADDITIONAL DEVICES WERE USED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2014 (71 DAYS POST-PROCEDURE), THE PATIENT WAS SEEN IN FOLLOW-UP. THE STATUS OF THE ANEURYSM WAS NOT SPECIFIED. DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, MIGRATION OR ENDOLEAKS. THERE WAS EVIDENCE OF THROMBUS IN THE RIGHT ILIAC LEG. ON (B)(6) 2014 (103 DAYS POST PROCEDURE), THE PATIENT EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK). ON THE SAME DAY, A SECONDARY INTERVENTION WAS PERFORMED TO TREAT THROMBOSIS IN THE RIGHT ILIAC LEG. THE SECONDARY INTERVENTION INCLUDED FEMOROFEMORAL BYPASS. ON (B)(6) 2015 (413 DAYS POST-PROCEDURE), THE PATIENT WAS SEEN IN FOLLOW-UP. THERE WAS NO CHANGE IN THE SIZE OF THE ANEURYSM. THE DEVICES WERE OCCLUDED IN THE MAIN BODY, RIGHT ILIAC LEG AND LEFT ILIAC LEG. THERE WAS EVIDENCE OF EXTERNAL COMPRESSION IN THE RIGHT ILIAC LEG. THERE WAS EVIDENCE OF THROMBUS IN THE MAIN BODY, RIGHT ILIAC LEG (1820334-2015-00781) AND LEFT ILIAC LEG (1820334-2015-00831). THERE WAS NO EVIDENCE OF FLOW-LIMITING KINKS, MIGRATION OR ENDOLEAKS. ON THE SAME DAY, THE PATIENT EXPERIENCED CLINICAL SIGNS INDICATIVE OF LOWER EXTREMITY ISCHEMIA AND UNDERWENT A SECONDARY INTERVENTION TO TREAT THROMBOSIS IN BOTH THE RIGHT AND LEFT ILIAC LEGS. THE INTERVENTION INCLUDED THROMBECTOMY AND COVERED STENT PLACEMENT. NO FURTHER FOLLOW-UP INFORMATION HAS BEEN PROVIDED.

Description of Event or Problem · 1

A (B)(6) YR OLD MALE PATIENT IN THE (B)(6) POST-MARKET REGISTRY ((B)(4)) EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK) ON (B)(6) 2014 ((B)(4) DAYS POST PROCEDURE) AND LOWER EXTREMITY ISCHEMIA ((B)(4) DAYS POST PROCEDURE). THE PATIENT WAS TREATED ON (B)(6) 2014 FOR AN AORTIC ANEURYSM. THE MAXIMUM AORTIC DIAMETER WAS 58 MM. THE PROXIMAL NECK HAD AN IRREGULAR SHAPE WITH PARTIAL PLAQUE/THROMBUS. THE BILATERAL ILIAC ARTERIES HAD MILD TORTUOSITY, NO OCCLUSIVE DISEASE, AND MILD CALCIFICATION. THE PATIENT RECEIVED A 22MM X 98MM MAIN-BODY DEVICE(ANOTHER MANUFACTURER), A 16MM X 74MM LEFT ILIAC LEG, AND A 16MM X 56MM RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER PROCEDURES WERE PERFORMED AND NO ADDITIONAL DEVICES WERE USED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2014 ((B)(4) DAYS POST-PROCEDURE), THE PATIENT WAS SEEN IN FOLLOW-UP. THE STATUS OF THE ANEURYSM WAS NOT SPECIFIED. DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, MIGRATION OR ENDOLEAKS. THERE WAS EVIDENCE OF THROMBUS IN THE RIGHT ILIAC LEG. ON (B)(6) 2014 ((B)(4) DAYS POST PROCEDURE), THE PATIENT EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK). ON THE SAME DAY, A SECONDARY INTERVENTION WAS PERFORMED TO TREAT THROMBOSIS IN THE RIGHT ILIAC LEG. THE SECONDARY INTERVENTION INCLUDED FEMOROFEMORAL BYPASS. ON (B)(6) 2015 ((B)(4) DAYS POST-PROCEDURE), THE PATIENT WAS SEEN IN FOLLOW-UP. THERE WAS NO CHANGE IN THE SIZE OF THE ANEURYSM. THE DEVICES WERE OCCLUDED IN THE MAIN BODY, RIGHT ILIAC LEG AND LEFT ILIAC LEG. THERE WAS EVIDENCE OF EXTERNAL COMPRESSION IN THE RIGHT ILIAC LEG. THERE WAS EVIDENCE OF THROMBUS IN THE MAIN BODY, RIGHT ILIAC LEG (1820334-2015-00781) AND LEFT ILIAC LEG (1820334-2015-00831). THERE WAS NO EVIDENCE OF FLOW-LIMITING KINKS, MIGRATION OR ENDOLEAKS. ON THE SAME DAY, THE PATIENT EXPERIENCED CLINICAL SIGNS INDICATIVE OF LOWER EXTREMITY ISCHEMIA AND UNDERWENT A SECONDARY INTERVENTION TO TREAT THROMBOSIS IN BOTH THE RIGHT AND LEFT ILIAC LEGS. THE INTERVENTION INCLUDED THROMBECTOMY AND COVERED STENT PLACEMENT. NO FURTHER FOLLOW-UP INFORMATION HAS BEEN PROVIDED.

Description of Event or Problem · 1

NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
773845	ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG	MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	COOK INC	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention