Zenith Spiral-Z G55243Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10827002552439), received between Nov 19, 2014 and Oct 20, 2023 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS PROVIDED ON 03NOV2023. THE INITIAL ENDOVASCULAR AORTIC REPAIR (EVAR) WAS COMPLETED ON (B)(6) 2013. THE COMPLAINT DEVICE (ZSLE-20-93-ZT) WAS PLACED ON THE RIGHT. A SECONDARY PROCEDURE WAS COMPLETED (DATE UNKNOWN) TO ADDRESS A TYPE 1A ENDOLEAK ON THE ZALB-28-108 AND A COOK CUSTOM FENESTRATED-THORACOABDOMINAL-DEVICE WAS PLACED. THE TYPE 3B ENDOLEAK APPEARED AFTER THE FENESTRATED PROCEDURE. THE AREA OF THE TYPE 3 ENDOLEAK WAS NOT TORTUOUS OR CALCIFIED. HOWEVER, THERE WAS THROMBUS. TO TREAT THE TYPE 3 ENDOLEAK, A COMPETITOR'S DEVICE WAS PLACED. FOLLOWING THE REINTERVENTION, THE PATIENT WAS REPORTED TO BE "OKAY."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17978271 ↗
• InjuryJan 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Clinical Endoleak

  MAUDE report 16087561 ↗
• MalfunctionAug 30, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE DILATOR OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DELIVERY SYSTEM WAS DIFFICULT TO ADVANCE OVER THE WIRE DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE ON AN UNKNOWN PATIENT. AN ATTEMPT WAS MADE TO LOAD THE ILIAC LIMB EXTENSION ONTO THE WIRE PRIOR TO PATIENT CONTACT. APPROXIMATELY TEN INCHES OF THE WIRE WAS LOADED INTO THE DILATOR TIP WHEN THE PHYSICIAN EXPERIENCED "PRONOUNCED STOPPAGE." THE DEVICE WAS THEN FLUSHED AND THE SHIPPING STYLET WAS RELOADED INTO THE BACK END OF THE DEVICE IN AN ATTEMPT TO CLEAR ANY OBSTRUCTIONS. ANOTHER ATTEMPT WAS MADE TO LOAD THE DEVICE BACK ONTO THE WIRE, BUT THE DEVICE COULD NOT BE ADVANCED FURTHER. THE WIRE WAS EXAMINED AND NO ISSUES WERE IDENTIFIED. A DIFFERENT DILATOR TIP FROM ANOTHER DEVICE ON THE BACK TABLE WAS UTILIZED TO SUCCESSFULLY ADVANCE THE DEVICE PER USUAL PROTOCOL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. WHEN EXAMINING THE DEVICE IN THE LIGHT, IT WAS DISCOVERED THAT THE ISSUE WAS WITH THE INSIDE OF THE DILATOR TIP AND NOT WITH THE WIRE. ADDITIONAL INFORMATION REGARDING DEVICE AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324205 ↗
• MalfunctionFeb 24, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS DIFFICULT TO ADVANCE OVER THE WIRE DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. USING A COMPETITOR'S WIRE, THE USER HAD DIFFICULTY ADVANCING THE DEVICE OVER THE WIRE. IT WAS NOTED THAT THE COATING ON THE WIRE GUIDE WAS COMING OFF. IT IS CURRENTLY UNKNOWN IF THE PATIENT HAD TORTUOUS/CALCIFIED ANATOMY. THE DEVICE WAS REMOVED AND A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13594039 ↗
• InjuryFeb 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 3B ENDOLEAK OCCURRED ON A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE DEVICE WAS PLACED IN THE EXTERNAL ILIAC ARTERY, AS WAS PLANNED DUE TO AN OCCLUDED RIGHT INTERNAL ILIAC ARTERY. DURING DEPLOYMENT OF THE DEVICE, IT WAS NOTED THERE WAS NARROWING IN THE DISTAL SEGMENT. THE SURGEONS APPLIED HIGH FORCE IN BALLOONING THE NARROWED DISTAL SEGMENT. HOWEVER, DUE TO HIGH PRESSURE, THE GRAFT WAS PERFORATED AND CONTRAST WAS VISIBLE IN THE ANEURYSM. THE TORN LIMB OF THE DEVICE WAS RELINED USING A SHORT ILIAC LEG GRAFT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICE REMAINS IN THE PATIENT AND WILL NOT BE EXPLANTED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13475414 ↗
• MalfunctionJun 4, 2021Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11941025 ↗
• MalfunctionMar 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392849 ↗
• InjuryNov 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN ENDOLEAK PERSISTED FOLLOWING IMPLANTATION OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING A RELINING PROCEDURE. A TYPE 3 ENDOLEAK WAS DISCOVERED VIA CT IMAGING DURING A FOLLOW-UP. THE EXACT LOCATION OF THE ENDOLEAK WAS UNABLE TO BE DETERMINED. CONSEQUENTLY, A FOLLOW-UP PROCEDURE WAS SCHEDULED. THE PATIENT WAS BROUGHT IN FOR "LIMB EXTENSION OR CUFF PROCEDURE" AS THE PHYSICIAN WAS INITIALLY UNSURE WHICH PROCEDURAL APPROACH WAS APPROPRIATE. SEVERAL ANGIOGRAPHIES WERE COMPLETED AND THE RIGHT LIMB WAS RELINED FROM TOP TO BOTTOM. FOLLOWING BALLOONING AND ANOTHER ANGIOGRAPHY, LEAKING WAS STILL OCCURRING. TWO COMPETITOR BALLOONS WERE THEN USED IN AN ATTEMPT TO EXPAND AND ANOTHER ANGIOGRAPHY WAS PERFORMED, WHICH SHOWED THAT THOUGH THE SITUATION HAD IMPROVED, THERE WAS STILL LEAKING PRESENT FROM AN UNDETERMINED LOCATION. AS A RESULT, TWO COMPETITOR LEG GRAFTS WERE IMPLANTED, ONE ON EACH SIDE AS THE EXACT LOCATION OF THE LEAKING WAS UNDETERMINED. A COOK BALLOON WAS USED ON BOTH SIDES AND A FINAL ANGIOGRAPHY WAS COMPLETED, SHOWING NO ENDOLEAKS PRESENT. A 30CC SYRINGE WAS USED THROUGHOUT THE PROCEDURE. BALLOONING WAS COMPLETED IN THE MID

  Patient problems: No Code Available

  MAUDE report 10896171 ↗
• InjuryDec 12, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG HAS STENOSED WHILE IN THE PATIENT. ON (B)(6) 2017, A (B)(6) YEAR OLD MALE PATIENT HAD 4 COOK AND 4 NON-COOK DEVICES IMPLANTED. THERE WERE NO DIFFICULTIES DEPLOYING ANY OF THE DEVICES AND THE POST-PROCEDURE IMAGING REVEALED NO EVIDENCE OF MIGRATION, SEPARATION OF COMPONENTS, DEVICE INTEGRITY ISSUES, OR ENDOLEAKS. ON (B)(6) 2017, THE PATIENT HAD POST-PROCEDURE IMAGING THAT REVEALED NO EVIDENCE OF MIGRATION, SEPARATION OF COMPONENTS, DEVICE INTEGRITY ISSUES, OR ENDOLEAKS. THE MAXIMUM ANEURYSM DIAMETER WAS 60MM. ON (B)(6) 2018, THE PATIENT HAD POST-PROCEDURE IMAGING THAT REVEALED NO EVIDENCE OF MIGRATION, SEPARATION OF COMPONENTS, DEVICE INTEGRITY ISSUES, OR ENDOLEAKS. THE MAXIMUM ANEURYSM DIAMETER WAS 57MM. ON (B)(6) 2018, THE PATIENT HAD POST-PROCEDURE IMAGING THAT REVEALED NO EVIDENCE OF MIGRATION, SEPARATION OF COMPONENTS, DEVICE INTEGRITY ISSUES, OR ENDOLEAKS. THE MAXIMUM ANEURYSM DIAMETER WAS 60MM. ON (B)(6) 2019 (602 DAYS POST PROCEDURE), THE PATIENT EXPERIENCED LEFT ILIAC LEG STENOSIS OF THE DEVICE. THE EVENT WAS DESCRIBED AS "PERIPHERAL ARTERIAL OBSTRUCTIVE DISEASE IN LEFT LEG". THE EVENT W

  Patient problems: No Code Available

  MAUDE report 9458424 ↗
• MalfunctionApr 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG HAD A "BLUSH OF CONTRAST OUTSIDE THE GRAFT BELOW THE OVERLAP OF THE BODY AND LIMB." DURING THE PLACEMENT OF A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, THERE WAS NO FLOW DOWN THE RIGHT ILIAC. THE CONTRAST RUN WAS PERFORMED AGAIN WHILE PULLING BACK THE SYRINGE IN THE RIGHT GROIN. THERE APPEARED TO BE FLOW, AS WELL AS A BLUSH OF CONTRAST OUTSIDE THE GRAFT BELOW THE OVERLAP OF THE BODY AND THE LIMB. THE FLUSH CATHETER WAS PULLED INTO THE LIMB. THE CONTRAST STUDY WAS REPEATED AND CONTRAST REMAINED OUTSIDE OF THE LIMB. THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS THEN RELINED. CONTRAST BLUSH WAS NO LONGER PRESENT AFTER ORIGINAL DEVICE WAS RELINED. HEPARIN WAS ADMINISTERED TO THE PATIENT DURING THE PROCEDURE. THE PATIENT'S VESSEL ANATOMY WAS NOT TORTUROUS, HOWEVER, THE PATIENT HAD A LITTLE BIT OF CALCIUM PRESENT AT THE BIFURCATION. THE SHAPE OF THE NECK ANATOMY WAS NOTED TO BE FAIRLY PARALLEL. THE GRAFT WAS BALLOONED AT THE OVERLAP OF THE GRAFT AND SEAL ZONES, ALTHOUGH THE EXACT INFLATION VOLUME IS UNKNOWN. THERE WAS NO GRAFT OBSTRUCTI

  Patient problems: No Code Available

  MAUDE report 8488604 ↗
• InjuryFeb 6, 2019Obstruction of Flow; Obstruction of Flow

  ADDITIONAL COMMENTS FROM THE PHYSICIAN. "WE DON¿T HAVE ANY CONCERNS ABOUT THE GRAFT PER SE. IT WAS REALLY ABOUT POSSIBLE THERAPEUTIC OPTIONS IN THE ACUTE SETTING. HOWEVER THIS GENTLEMAN HAS SETTLED ON IV HEPARIN. HAEMATOLOGY GOT INVOLVED AND SUGGESTED PLAVIX AND CHANGING HIS ANTICOAGULANT. HE HAD ORIGINALLY PRESENTED WITH EMBOLISATION FROM HIS NATIVE AORTA AND REQUIRED A HALLUX AMPUTATION. WE DIDN¿T FIX HIS AORTA AT THAT TIME AS IT WAS LESS THAN 5.5 AND COMMENCED ON PLAVIX. SOME MONTHS LATER HE REPRESENTED WITH AN ISCHAEMIC 2ND TOE AND WE THEN DECIDED TO FIX HIM. HE WAS JUST ABOUT 5.5CM POST OPERATIVELY HE DEVELOPED FAST AFIB AND WAS ANTI COAGULATED AND IN FACT HIS INR WAS 3.5 AT THE TIME OF HIS PRESENTATION ON THIS ADMISSION. HIS ANTI PHOSPHOLIPID ANTIBODY WAS WEAKLY POSITIVE SO AGAIN HAEMATOLOGY ARE FOLLOWING THIS".

  Patient problems: No Code Available; Pain; Thrombus

  MAUDE report 8313357 ↗
• InjuryJan 29, 2019Fluid/Blood Leak; Migration; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT THE DEVICES MIGRATED DISTALLY TOGETHER AND CAUSED AN ENDOLEAK THAT LED TO A RUPTURED AORTIC ANEURYSM AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY (IMA). THE DEVICES WERE ORIGINALLY IMPLANTED AT A DIFFERENT HOSPITAL ON (B)(6) 2013. THE SURGEON COMPLETED AN OPEN JUXTARENAL ANEURYSM REPAIR. THE PATIENT IS CURRENTLY RECOVERING IN THE HOSPITAL. THE PATIENT DID ATTEND FOLLOW UP APPOINTMENTS AS RECENTLY AS (B)(6) 2018 WITH THE PHYSICIAN THAT INITIALLY IMPLANTED THE COMPLAINT DEVICES. THIS REPORT ADDRESSES THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (ZSLE-20-90-ZT, LOT 3819572) THAT MIGRATED DISTALLY. THE FOLLOWING REPORTS ARE RELATED IN REFERENCE AS THE TWO ADDITIONAL DEVICES WERE REPORTED TO MIGRATE DISTALLY AS WELL: 1820334-2019-00264 - TFFB-36-95, LOT 3902292. 1820334-2019-00266 - ZSLE-20-39-ZT, LOT 2793747.

  Patient problems: Aneurysm; No Code Available; Rupture

  MAUDE report 8286392 ↗
• InjuryJul 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018.THE OCCLUSION WAS DISCOVERED DURING CT SCAN PERFORMED ON (B)(6) 2018.

  Patient problems: Ambulation or Postural Difficulties; Claudication; Occlusion

  MAUDE report 7698836 ↗
• MalfunctionMay 15, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED, DURING PREPARATION, IT WAS UNABLE TO REMOVE AIR FROM THE DELIVERY SYSTEM BY FLUSHING BECAUSE THE FLUSHING FLUID LEAKED FROM THE HEMOSTATIC VALVE. ANOTHER ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT IMPACT WAS REPORTED AS THE MALFUNCTION WAS DISCOVERED PRIOR TO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7516081 ↗
• MalfunctionDec 21, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE PHYSICIAN HAD DIFFICULTY RETRACTING THE MAIN BODY SHEATH AND WAS UNABLE TO DEPLOY THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140211 ↗
• MalfunctionDec 5, 2017Cut In Material; Cut In Material

  IT WAS REPORTED THAT THE TIP OF THE DILATOR OF THE DELIVERY SYSTEM OF THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT WAS DAMAGED (CUT) BY THE WIRE DURING THE ADVANCEMENT OF THE DELIVERY SYSTEM OVER THE WIRE IN PREPARATION TO ADVANCE THE DEVICE THROUGH THE VESSEL. THE PHYSICIAN ATTEMPTED TO CUT OFF THE DILATOR TIP BUT THE TOOL THEY WERE USING BECAME HOOKED ON THE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO UNINTENDED PORTION OF THE DEVICE LEFT IN THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7084674 ↗
• MalfunctionJul 18, 2017Leak/Splash

  IT WAS NOTED THAT PRIOR TO USING ON THE PATIENT FOR AN ABDOMINAL AORTIC ANEURYSM REPAIR, THE CAPTOR VALVE WAS LEAKING WHEN FLUSHED WITH HEPARANIZED SALINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723646 ↗
• MalfunctionJul 18, 2017Fluid/Blood Leak

  THE INFORMATION RECEIVED INDICATED THAT WHEN THE CAPTOR VALVE WAS FLUSHED WITH HEPARINIZED SALINE, THE VALVE WAS NOTED TO BE LEAKING. THIS OCCURRED PRIOR TO PATIENT CONTACT FOR AN ABDOMINAL AORTIC ANEURYSM REPAIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723146 ↗
• MalfunctionMay 25, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE USING A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, FOR (B)(6) EXPERIENCED ARTERIAL THROMBOSIS (COMPLETE OCCLUSION) IN RIGHT (IPSILATERAL) ILIAC LIMB 722 DAYS POST-PROCEDURE. UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT PLACEMENT OF A THREE-PIECE AAA ENDOVASCULAR GRAFT. A 30 MM X 108 MM MAIN BODY COMPONENT (ZALB-30-108-CI; 5079312), A 20 MM X 90 MM IPSILATERAL (RIGHT) ILIAC LEG GRAFT (ZSLE-20-90-ZT; 5640213), AND A 16 MM X 90 MM CONTRALATERAL (LEFT) ILIAC LEG GRAFT (ZSLE-16-90-ZT; 5738902) WERE DEPLOYED. THE PROXIMAL EDGE OF THE GRAFT MATERIAL WAS DEPLOYED DISTAL TO THE RENAL ARTERIES. A MOLDING BALLOON WAS USED DURING THE PROCEDURE WITHOUT DIFFICULTY OR COMPLICATIONS. NO ANCILLARY COMPONENTS WERE USED AND NO ADDITIONAL PROCEDURES WERE PERFORMED. THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE ENDOVASCULAR GRAFT WAS PATENT WITH NO EVIDENCE OF A KINK OR AN ENDOLEAK. CORE LAB ANALYSIS OF THE COMPLETION ANGIOGRAM NOTED A PATENT GRAFT WITH NO EVIDENCE OF A KINK OR ENDOLEAKS. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 100 CC AND NO BLOOD PRODUCTS WERE GIVEN INTRA-OPERATIVELY. NO PATIENT

  Patient problems: Thrombosis

  MAUDE report 6590247 ↗
• InjuryDec 7, 2016Leak/Splash; Leak/Splash

  AN (B)(6) MALE PATIENT UNDERWENT A AAA REPAIR IN (B)(6) 2016. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. AFTER PLACING ALL STENT GRAFTS AS PLANNED, AN EXCESSIVE AMOUNT OF TYPE IV ENDOLEAK WAS CONFIRMED BY FINAL ANGIOGRAPHY. ANOTHER STENT GRAFT WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED AS OF THE DATE OF THIS REPORT. THE INITIAL REPORT FOR THIS EVENT WAS FILED UNDER MED-WATCH# 1820334-2016-01064, ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2016 REGARDING THE SPECIFIC DEVICES. TWO ADDITIONAL COMPLAINTS WERE OPENED TO ADDRESS THE ADDITIONAL PRODUCTS AND MED-WATCH REPORTS INITIATED UNDER: MED-WATCH# 1820334-2016-01429 FOR PART ZSLE-20-90-ZT (THIS REPORT). MED-WATCH# 1820334-2016-01430 FOR PART ZSLE-24-74-ZT.

  Patient problems: No Code Available

  MAUDE report 6151949 ↗
• InjuryAug 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, IT WAS DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR, THAT THE SURGICAL TEAM HAD TWO 90 MM WORKING LENGTH ILIAC LEG DEVICES ON A TABLE, ONE WITH A DISTAL DIAMETER OF 13 MM AND THE OTHER WITH A DISTAL DIAMETER OF 20 MM. THE TEAM SELECTED THE WRONG DILATOR TO INSERT THE SHEATH; RESULTING IN AN UNSMOOTH TRANSITION, DUE TO THE SIZE DIFFERENCE. THERE WAS A NOTCH FROM THE ARTERY; RESULTING IN THE LOSS OF BLOOD. THE BLOOD LOSS WAS REPORTED TO HAVE BEEN MANAGEABLE BY THE SURGEON. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY, AS PLANNED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT AT THE TIME OF THIS REPORT, NO RESPONSE HAS BEEN PROVIDED.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 5903913 ↗
• InjuryFeb 25, 2015Hole In Material; Leak/Splash

  AN (B)(6) PT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR APPROXIMATELY 3 YEARS AGO. THE PT PRESENTED RECENTLY WITH ABDOMINAL PAIN AND WAS HOSPITALIZED HAVING A NEW CT SCAN DONE. THE SCAN IDENTIFIED A CONTAINED RUPTURE OF THE AAA ALONG WITH A PAST ENDOLEAK WHERE EMBOLIZATION COILS HAD BEEN USED. THE PT WAS TAKEN TO OPEN PROCEDURE WITH THE PLANS FOR EXPLANTING THE GRAFT. HOWEVER, A PIN HOLE WAS NOTED IN THE EXISTING ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PHYSICIAN SEWED A PLEDGET OVER THE HOLE. ACCORDING TO THE REPORTER, THE PT IS DOING WELL AND THE PHYSICIAN HAS ANTICIPATED THE PT TO BE RELEASED ON (B)(6) 2015. ORIGINAL EVAR DOS WAS (B)(6) 2012. COMPLETE DEVICE DETAILS WERE NOT AVAILABLE AND NO LOT NUMBERS WERE LISTED. THE MAIN BODY WAS INTRODUCED THROUGH THE LEFT GROIN. UPON SUBSEQUENT FOLLOW UP, TYPE II ENDOLEAK WAS SUSPECTED, AND L3/L4 LUMBARS WERE COILED EMBOLIZED THROUGH DIRECT SAC PUNCTURE. ON (B)(6) 2013, AN ADDITIONAL TYPE II ENDOLEAK AT THE BOTTOM OF THE SAC WAS NOTED BY THE PHYSICIAN. THE PHYSICIAN NOTED A PIN HOLE IN THE IPSILATERAL (LEFT) ZSLE WHEN HE OPENED THE ABDOMEN AND INSPECTED THE GRAFTS (B)(6) 2015.

  Patient problems: Abdominal Pain

  MAUDE report 4561888 ↗
• InjuryNov 19, 2014Occlusion Within Device

  A (B)(6) MALE PATIENT WHO WAS NOT A CANDIDATE FOR OPEN REPAIR UNDERWENT EVAR WITH ZENITH AAA DEVICES ON (B)(6) 2013. THE PATIENT UNDERWENT A REPAIR ON (B)(6) 2014 DUE TO ACUTE THROMBOSIS OF THE RIGHT LIMB OF THE STENT GRAFT WITH CONSEQUENT DEVELOPMENT OF CRITICAL LIMB ISCHEMIA AND THERE WAS EVIDENCE OF EARLY STENOSIS OF THE LEFT LIMB. THE PHYSICIAN PERFORMED PTA AND STENTING ON THE LEFT SIDE (USING PATIENT DONOR ILIAC) AND A SURGICAL FEM-FEM CROSS-OVER.

  Patient problems: Surgical procedure, additional

  MAUDE report 4279039 ↗