Zenith Flex G48432Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10827002484327), received between Nov 5, 2014 and Dec 30, 2024 — classified as 3 deaths, 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS PROVIDED ON 07JAN2025. THE DELIVERY SYSTEM OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS FLUSHED WITH 40 CC¿S OF HEPARINIZED SALINE PRIOR TO ORIENTING THE CONTRALATERAL GATE CHECK MARK UNDER FLUOROSCOPY. THE CUSTOMER AND COOK SALES REPRESENTATIVE BELIEVED THAT IT WAS THE VALVE THAT LEAKED. IT WAS REPORTED THAT IT WAS POSSIBLE THAT THE VALVE MAY HAVE BEEN DAMAGED WHEN REMOVING THE PEEL AWAY SHEATH DURING GRAFT PREPARATION. THE SCRUB TECHNICIAN PEELED THE PEEL AWAY SHEATH APART UNTIL IT RIPPED. TYPICALLY, THE TECHNICIAN STOPS ONCE THE PEEL AWAY SHEATH REACHES THE VALVE. THEN, THE TECHNICIAN STABILIZES THE DEVICE AND SLIDES THE REMAINING PEEL AWAY SHEATH OUT OF THE VALVE BEFORE COMPLETELY REMOVING IT. BEFORE THE CATHETER COULD BE INSERTED TO MEASURE FOR IPSILATERAL LIMB, THE VALVE WAS NOTICED TO BE LEAKING AFTER REMOVING THE DILATOR. AT THIS POINT, THE VALVE WAS CLOSED AND IT STILL CONTINUED TO LEAK. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DELIVERY SYSTEM WAS REMOVED AND WAS REPLACED WITH A COMPETITOR'S SHEATH WITH THE SAME DIAMETER WHICH WAS READILY AVAILABLE IN THE OPERATING ROOM. THE PATIENT DID NOT REQUIRE A TRANS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21035172 ↗
• InjuryJan 9, 2024Material Separation; Activation Failure; Material Separation; Activation Failure

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

  Patient problems: Insufficient Information

  MAUDE report 18477506 ↗
• InjuryAug 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IN 2014 A PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE WHERE THE FOLLOWING COOK GRAFTS WERE PLACED: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT , LOT NUMBER 4053084); ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION (RPN: ZBIS-10-45-41, LOT NUMBER A937127) ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-56-ZT, LOT NUMBER 4715582); ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-20-56-ZT, LOT NUMBER 4792180). IN 2020 A REINTERVENTION PROCEDURE WAS COMPLETED. THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (RPN: TFFB-36-95-ZT LOT NUMBER 4053084) LOST WALL APPOSITION PROXIMALLY CREATING A TYPE 1A ENDOLEAK. A FENESTRATED TUBE GRAFT (MANUFACTURER UNKNOWN) WAS PLACED DURING THE SECONDARY PROCEDURE. A COMPUTED TOMOGRAPHY SCAN WAS COMPLETED ON (B)(6) 2023 AND AN ENDOLEAK WAS NOTED AND THOUGHT TO BE A TYPE 3B ENDOLEAK. AN ULTRASOUND BUBBLE TEST WAS ALSO PERFORMED AFTER THE REINTERVENTION PROCEDURE IN 2020. ON (B)(6) 2023 A REINTERVENTION PROCEDURE WAS COMPLETED WITH THE INTENTION TO RELINE THE DISTAL END OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED M

  Patient problems: Clinical Endoleak

  MAUDE report 17662370 ↗
• InjuryJun 29, 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: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17227219 ↗
• InjuryMar 10, 2023Complete Blockage; Difficult to Advance; Complete Blockage; Difficult to Advance

  ADDITIONAL INFORMATION WAS PROVIDED ON 08JUN2023. THE COOK SALES REPRESENTATIVE SPOKE WITH THE IMPLANTING PHYSICIAN. THE IMPLANTING PHYSICIAN DOES NOT BELIEVE THE ADVERSE EVENT WAS ATTRIBUTED TO THE IMPLANT. THE PATIENT WAS EMERGENTLY TRANSFERRED TO ANOTHER FACILITY. AT THAT FACILITY THE GRAFTS WERE EXPLANTED AND AN ABDOMINAL AORTIC ANEURYSM (AAA) BYPASS WAS COMPLETED. THE PATIENT CONTINUED TO HAVE CLOTTING ISSUES. THE PATIENT'S CURRENT STATUS US UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16522009 ↗
• InjuryJan 13, 2023Fracture; Material Separation; Fracture; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED ON 09FEB2023 REGARDING THE DEVICES IMPLANTED IN THE PATIENT.

  Patient problems: Aneurysm expansion

  MAUDE report 16164869 ↗
• InjuryApr 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A TYPE 1 ENDOLEAK OCCURRED ON AN UNKNOWN ZENITH FLEX GRAFT. THE PATIENT REQUIRED OPEN REPAIR AND THE DEVICE WAS EXPLANTED. A SYNTHETIC POLYESTER GRAFT WAS PLACED. IN THE SAME WEEK FOLLOWING THE OPEN PROCEDURE, THE PATIENT REQUIRED A COLECTOMY WITH A CLIP AND DROP APPROACH. FOLLOWING THE COLECTOMY, THE PATIENT REQUIRED AN ILEOSTOMY PROCEDURE. THE PATIENT IS REPORTEDLY "STILL ALIVE". ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information; Ruptured Aneurysm

  MAUDE report 14254859 ↗
• InjuryDec 22, 2021Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT A USER EXPERIENCED DIFFICULTY ADVANCING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, RESULTING IN RUPTURE OF THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT'S RIGHT ILIAC ARTERY WAS REPORTED TO BE CALCIFIED. AS THE DEVICE WAS ADVANCED, IT WAS "TOO LARGE TO PASS THROUGH". CONSEQUENTLY, THE PATIENT'S RIGHT ILIAC ARTERY RUPTURED AND REQUIRED A COMPETITOR STENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Perforation of Vessels; Rupture

  MAUDE report 13064212 ↗
• MalfunctionJan 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IN ADDITIONAL INFORMATION RECEIVED ON 16JUN2021 IT WAS NOTED THAT THE DEVICE WOULD NOT BE RETURNED, AS IT HAD BEEN THROWN AWAY.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11251983 ↗
• MalfunctionSep 1, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE TOP CAP OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DID NOT DEPLOY CORRECTLY DURING AN EVAR PROCEDURE. DURING IMPLANTATION OF THE DEVICE, THE PHYSICIAN BEGAN TO ATTEMPT TO DEPLOY THE TOP CAP AND WAS ABLE TO REMOVE THE TRIGGER WIRE OF THE TOP CAP WITHOUT ISSUE AND PROCEEDED TO UNSCREW THE PIN VICE APPROXIMATELY TWO TURNS. THE PHYSICIAN THEN "PINNED THE WIRE" AND ADVANCED THE METAL CANNULA UPWARDS TOWARDS THE PATIENT'S HEAD. WHILE ATTEMPTING TO ADVANCE THE METAL CANNULA, IT WAS OBSERVED THROUGH FLUOROSCOPY THAT THE TOP CAP WAS NOT DEPLOYING. THE PHYSICIAN LOOSENED THE PIN VICE ONE MORE TURN TO ENSURE THAT IT WAS LOOSE BEFORE REATTEMPTING TO ADVANCE. AFTER DOING SO, FLUOROSCOPY IMAGING REVEALED THAT THE TOP CAP WAS ONLY ONE FOURTH DEPLOYED AND UNABLE TO BE FURTHER ADVANCED. AS REPORTED, IT BECAME "STUCK AT THAT SEGMENT". IN RESPONSE, THE PHYSICIAN BEGAN TO EXERT MORE FORCE ON THE METAL CANNULA IN ATTEMPT TO FURTHER ADVANCE IT. THIS RESULTED IN THE METAL CANNULA BUCKLING WITHIN THE GRAFT (AS SEEN THROUGH THE FLUOROSCOPY SCREEN). UPON NOTICING THE BUCKLING, THE PHYSICIAN STOPPED ADVANCING, ALLOWING THE META CANNULA TO STRAIGHTEN OUT. THE PHYSICI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10480107 ↗
• DeathMay 21, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Death; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 10079853 ↗
• DeathApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION REGARDING EVENT DETAILS WAS RECEIVED ON 16APR2020. THE PATIENT DEVELOPED SEPTICEMIA THE EVENING OF THE PROCEDURE, WHICH WAS DETERMINED TO BE CAUSE OF DEATH. THE PATIENT BECAME SEPTIC AND WAS TAKEN TO (B)(6) HOSPITAL. THE GRAFTS WERE NOT EXPLANTED. NO DAMAGE WAS NOTED PRIOR TO USE OF THE DEVICE. THE PATIENT HAD A HISTORY OF BOWEL CANCER AND HEART DISEASE. THE PATIENT WAS ON BLOOD PRESSURE MEDICATION, STATINS, AND MEDICINE TO TREAT THE BOWEL CANCER PRIOR TO THE PROCEDURE.

  Patient problems: Death; Fever; Sepsis

  MAUDE report 9948146 ↗
• InjuryMar 25, 2020Fluid/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: Blood Loss; No Code Available

  MAUDE report 9880090 ↗
• MalfunctionAug 15, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2019, A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS LEAKING THROUGHOUT THE DURATION OF AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. PRIOR TO THE SURGERY, THE PATIENT HAD TORTUROUS ANATOMY. THE PROCEDURE, HOWEVER, WAS ABLE TO BE COMPLETED AS PLANNED AND DID NOT RESULT IN ANY ADVERSE EVENTS OR THE NEED FOR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8898749 ↗
• DeathFeb 25, 2019Leak/Splash; Leak/Splash

  THE PATIENT'S PRE-EXISTING CONDITION WAS AN AORTIC RUPTURE. THERE WAS A BIT OF ILIAC CALCIFICATION. TWO 46 CODA BALLOONS WERE ALSO USED DURING THE PROCEDURE IN THE PROXIMAL SEAL, AS WELL AS THE PREVIOUSLY REPORTED DEVICES. AN AUTOPSY REPORT WILL NOT BE PROVIDED AND A DEATH CERTIFICATE IS NOT AVAILABLE. THE CAUSE OF DEATH DETERMINED BY THE PHYSICIAN WAS BOWEL ISCHEMIA AND HEMODYNAMIC SHOCK. IT WAS REPORTED THAT THE PATIENT DEATH WAS POTENTIALLY PATIENT RELATED. THE EXPLANTED DEVICE IS NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. IMAGING WILL NOT BE PROVIDED FOR THE INVESTIGATION.

  Patient problems: Death; No Code Available

  MAUDE report 8367898 ↗
• 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 AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (TFFB-36-95, LOT 3902292) THAT MIGRATED DISTALLY. THE FOLLOWING REPORTS ARE RELATED IN REFERENCE AS THE TWO ADDITIONAL DEVICES WERE REPORTED TO MIGRATE DISTALLY AS WELL. 1820334-2019-00265 - (ZSLE-20-90-ZT, LOT 3819572); 1820334-2019-00266 - (ZSLE-20-39-ZT, LOT 2793747).

  Patient problems: Aneurysm; No Code Available; Rupture

  MAUDE report 8285534 ↗
• InjuryMar 22, 2018Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A SECONDARY INTERVENTION PROCEDURE THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY'S CONTRALATERAL GATE DID NOT OPEN. THE GRAFT WAS POSITIONED SO THAT THE CONTRALATERAL GATE OPENED TOWARDS THE FRONT WITH THE CONTRALATERAL TICK MARKER IN A POSTERIOR POSITION. WHEN A CODA BALLOON WAS INFLATED IN THE IPSILATERAL LIMB IT WAS EVIDENT THE CONTRALATERAL GATE WAS COMPRESSED AND HAD NOT OPENED FULLY. IT APPEARED TO BE JAMMED UP AGAINST THE AORTIC WALL AND IT WAS IMPOSSIBLE TO GAIN ACCESS TO THIS PART OF THE GRAFT. THE DOCTOR ATTEMPTED TO CANNULATE THE CONTRALATERAL GATE VIA THE RIGHT COMMON ILIAC ARTERY TO NO AVAIL AND THEN TRIED VIA A BRACHIAL APPROACH. AFTER TRYING FOR 3 HOURS TO CANNULATE, A DECISION WAS MADE TO CONNECT THE RIGHT IBD TO THE IPSILATERAL LIMB WITH A ZSLE. THE PATIENT WAS TAKEN TO OPERATING ROOM FOR A FEMORAL TO FEMORAL BYPASS GRAFT TO RESTORE BLOOD FLOW TO THE LEFT LEG.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7361391 ↗
• InjuryDec 19, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED VIA A VOLUNTARY MEDWATCH ADVERSE EVENT REPORT THAT A MALE PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR AND HAD A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IMPLANTED ON (B)(6) 2012. THE PATIENT DEVELOPED A TYPE III ENDOLEAK REQUIRING PLACEMENT OF A NEW GRAFT. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION REGARDING PRE-EXISTING CONDITIONS, AVAILABILITY OF IMAGING, AND OUTCOME OF THE SECONDARY PROCEDURE; HOWEVER THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION.

  Patient problems: No Code Available

  MAUDE report 7129472 ↗
• MalfunctionJul 13, 2017Fluid/Blood Leak

  DURING PREPARATION OF THE STENT GRAFT IT WAS NOTED THAT WHILE FLUSHING THE HEMOSTASIS VALVE, FLUID LEAKED HEAVILY FROM THE BACK OF THE VALVE. THIS WAS DISCOVERED PRIOR TO PATIENT CONTACT AND ANOTHER DEVICE WAS USED FOR THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6712358 ↗
• InjuryJul 28, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PATIENT UNDERWENT AAA ENDOVASCULAR REPAIR WITH LEFT APPROACH. THE PATIENT'S ANATOMICAL FORM WAS DETERMINED TO BE SUITABLE FOR THE PROCEDURE. DURING PREPARATION OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT LEAKAGE OF SALINE FLUSHING SOLUTION FROM THE HEMOSTATIC VALVE BETWEEN THE CAPTOR ROTATOR AND GRAY PART OF THE CAPTOR VALVE WAS OBSERVED. THERE WAS NO REPLACEMENT OF THE SAME DIAMETER DEVICE AT THE FACILITY. THE PHYSICIAN THOUGHT THE DEVICE COULD BE USED FOR THE PROCEDURE EVEN THOUGH THE LEAKAGE WAS REPORTED TO BE A LITTLE WORSE THAN THE USUAL AMOUNT OF LEAKAGE OBSERVED PREVIOUSLY FROM THE HEMOSTATIC VALVE OF OTHER DEVICES. AFTER THE DEVICE WAS INSERTED IN THE PATIENTS' BODY (BEFORE DEPLOYMENT OF THE MAIN BODY), BLOOD LEAKAGE OCCURRED BETWEEN THE CAPTOR ROTATOR AND GRAY PART OF CAPTOR VALVE. AFTER THE MAIN BODY WAS DEPLOYED, BLOOD LEAKAGE WAS REPORTEDLY GETTING WORSE AND THE SHEATH NEEDED TO BE REMOVED AND WAS IMMEDIATELY CHANGED AFTER PLACEMENT IN THE MAIN BODY. REPORTEDLY USUALLY AFTER PLACEMENT OF THE MAIN BODY THE CONTRALATERAL LEG IS PLACED, HOWEVER, IN THIS CASE IPSILATERAL LEG WAS PLACED BEFORE CONTRALATERAL LEG. BLOOD LEAKAGE WAS CONTROLLED AFTER REMOVED TH

  Patient problems: Blood Loss

  MAUDE report 5828955 ↗
• MalfunctionMay 22, 2015Leak/Splash

  DURING AN ENDOVASCULAR AORTIC REPAIR ON A (B)(6) YEAR OLD MALE PATIENT ON (B)(6) 2015, THE CAPTOR VALVE OF THE ZENITH FLEX MAIN BODY WAS LEAKING. THE VALVE WOULD NOT CLOSE AND CONTINUED TO LEAK EVEN WITH A DILATOR IN PLACE. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE AS SCHEDULED WITH THE DEVICE AND THE PATIENT DID NOT NEED TRANSFUSION OR BLOOD PRODUCTS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4799466 ↗
• MalfunctionJan 20, 2015Leak/Splash

  ALL THREE DEVICES HAD DEPLOYMENT SYSTEM LEAKS DURING THIS PROCEDURE. THE MAIN BODY (1820334-2015-000440 LEAKED SUBSTANTIALLY FROM THE CAPTOR VALVE. BOTH LEGS (1820334-2015-00043 AND 1820334-2015-00042) LEAKED SOMEWHAT FROM THE CAPTOR VALVE. ALL THREE DEVICES WERE SUCCESSFULLY IMPLANTED. NO INTERVENTION WAS REQUIRED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4459017 ↗
• MalfunctionNov 5, 2014Leak/Splash

  PER INITIAL STATEMENT, THE HEMOSTATIC VALVE WAS LEAKING IN THE PROXIMAL PART OF THE VALVE DURING THE DEPLOYMENT OF THE GRAFT. PER REP IB (B)(6) 2014 THE PROCEDURE WENT WELL AND THE DEVICE IS IN PLACE WITHOUT ANY ISSUE. THE PHYSICIAN DID THE DEPLOYMENT AS QUICKLY AS POSSIBLE BECAUSE THE PATIENT WAS LOSING BLOOD ON PROXIMAL PART OF THE VALVE AS IT WAS LEAKING. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4254702 ↗