IntegrityRecalls & reported problems across all models

We found 27 models of Integrity by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Aug 10, 2022 — classified as 2 deaths, 26 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Integrity problems

Integrity models

27 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Integrity INT30018UX

  STENT, CORONARY
  6 reports
• Integrity INT25026UX

  STENT, CORONARY
  4 reports
• Integrity INT30009UX

  STENT, CORONARY
  3 reports
• Integrity INT30012UX

  STENT, CORONARY
  3 reports
• Integrity INT30030UX

  STENT, CORONARY
  3 reports
• Integrity INT40012UX

  STENT, CORONARY
  1 death3 reports
• Integrity INT25018UX

  STENT, CORONARY
  3 reports
• Integrity INT30030W

  STENT, CORONARY
  2 reports
• Integrity INT30015UX

  STENT, CORONARY
  2 reports
• Integrity INT30022UX

  STENT, CORONARY
  2 reports
• Integrity INT35022UX

  STENT, CORONARY
  2 reports
• Integrity INT40009UX

  STENT, CORONARY
  2 reports
• Integrity INT22512UX

  STENT, CORONARY
  2 reports
• Integrity INT22522UX

  STENT, CORONARY
  2 reports
• Integrity INT30022W

  STENT, CORONARY
  1 report
• Integrity INT35012UX

  STENT, CORONARY
  1 report
• Integrity INT35015UX

  STENT, CORONARY
  1 report
• Integrity INT35018UX

  STENT, CORONARY
  1 report
• Integrity INT35030UX

  STENT, CORONARY
  1 report
• Integrity INT40015UX

  STENT, CORONARY
  1 report
• Integrity INT40018UX

  STENT, CORONARY
  1 death1 report
• Integrity INT22508UX

  STENT, CORONARY
  1 report
• Integrity INT22514UX

  STENT, CORONARY
  1 report
• Integrity INT22526UX

  STENT, CORONARY
  1 report
• Integrity INT27514UX

  STENT, CORONARY
  1 report
• Integrity INT27522UX

  STENT, CORONARY
  1 report
• Integrity INT27526UX

  STENT, CORONARY
  1 report

Recent Integrity adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2022Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE A 6F TELESCOPE GUIDE EXTENSION CATHETER AND TWO INTEGRITY RX BARE METAL STENTS TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL SUBCLAVIAN ARTERY. A RADIAL APPROACH WAS USED. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS ENCOUNTERED WHEN USING THE TELESCOPE DEVICE WITH NON-MEDTRONIC GUIDEWIRES. THE TELESCOPE DEVICE WAS NOT EXCESSIVELY TORQUED. THE TELESCOPE DEVICE ENTERED THE VESSEL WITH TWO NON-MEDTRONIC GUIDEWIRES. IT WAS REPORTED THAT WHEN PUSHING THE INTEGRITY STENTS TO THE TARGET LESION THEY BECAME STUCK MIDWAY AND RESISTANCE WAS ENCOUNTERED. THE STENTS WERE STUCK AT THE ENTRY PORT OF THE TELESCOPE. IT WAS ALSO REPORTED THAT THE SECOND GUIDE WIRE BECAME TANGLED WITH THE TELESCOPE DEVICE AT THE PUSH WIRE SECTION BEFORE THE RAMP. AS A RESULT, IT WAS NOT POSSIBLE TO WITHDRAW THE WIRE AND THE WHOLE SYSTEM WAS RETREATED. THERE WERE NO ISSUES NOTED WITH THE FIRST GUIDEWIRE. THE GUIDEWIRES WERE EXAMINED AND FL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202611 ↗
• MalfunctionAug 10, 2022Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE A 6F TELESCOPE GUIDE EXTENSION CATHETER AND TWO INTEGRITY RX BARE METAL STENTS TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL SUBCLAVIAN ARTERY. A RADIAL APPROACH WAS USED. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS ENCOUNTERED WHEN USING THE TELESCOPE DEVICE WITH NON-MEDTRONIC GUIDEWIRES. THE TELESCOPE DEVICE WAS NOT EXCESSIVELY TORQUED. THE TELESCOPE DEVICE ENTERED THE VESSEL WITH TWO NON-MEDTRONIC GUIDEWIRES. IT WAS REPORTED THAT WHEN PUSHING THE INTEGRITY STENTS TO THE TARGET LESION THEY BECAME STUCK MIDWAY AND RESISTANCE WAS ENCOUNTERED. THE STENTS WERE STUCK AT THE ENTRY PORT OF THE TELESCOPE. IT WAS ALSO REPORTED THAT THE SECOND GUIDE WIRE BECAME TANGLED WITH THE TELESCOPE DEVICE AT THE PUSH WIRE SECTION BEFORE THE RAMP. AS A RESULT, IT WAS NOT POSSIBLE TO WITHDRAW THE WIRE AND THE WHOLE SYSTEM WAS RETREATED. THERE WERE NO ISSUES NOTED WITH THE FIRST GUIDEWIRE. THE GUIDEWIRES WERE EXAMINED AND FL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202281 ↗
• InjuryJan 7, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Material Deformation; Migration or Expulsion of Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE AN INTEGRITY RX CORONARY BARE METAL STENT TO TREAT THE LEFT VERTEBRAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE INTEGRITY BARE METAL STENT WAS PLACED IN A GUIDE SHEATH BUT THE GUIDE SHEATH BECAME DISLODGED, THEREFORE THE STENT WAS REMOVED TO REPOSITION IN THE GUIDE SHEATH. WHEN AN ATTEMPT WAS MADE TO USE A BALLOON TO DEPLOY THE STENT, IT WAS NOTICED THAT THE STENT HAD FALLEN OFF THE BALLOON AND INJECTION SHOWED THAT THE STENT HAD MIGRATED AND WAS FLOATING IN THE LEFT VERTEBRAL ARTERY UNEXPANDED. THE STENT WAS RETRIEVED AND REMOVED POSSIBLY USING A SNARE AND THE PROCEDURE WAS CONTINUED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13190188 ↗
• MalfunctionFeb 17, 2021Device Dislodged or Dislocated

  DURING A PROCEDURE, IT WAS INTENDED TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WAS NO ISSUES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. IT WAS REPORTED THAT THE STENT WAS NOTED TO BE MISSING FROM THE BALLOON CATHETER. IT WAS STATED THAT THE DEVICE WAS NOT USED IN THE PATIENT. IT WAS LATER CONFIRMED THAT THE BALLOON WAS INSERTED INTO THE LAD AND INFLATED. IT WAS NOT REALIZED THAT THERE WASN'T A STENT ON THE BALLOON. IT WAS STATED THAT A VERIFICATION CHECK WAS CONDUCTED VIA IVUS THAT THERE WAS NOT A STENT INSIDE THE PATIENT POST DEFLATION OF THE BALLOON. THE GUIDE CATHETER WAS ALSO CHECKED AFTER THE PROCEDURE TO VERIFY THAT THE STENT WAS NOT IN THE GUIDE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339718 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVASCULARIZATION PROCEDURE ONE RESOLUTE INTEGRITY BMS WAS IMPLANTED IN THE RCA. APPROXIMATELY 9 MONTHS LATER THE PATIENT WAS TREATED FOR SEVERELY CALCIFIED RCA AND INTENT RESTENOSIS OF THE MID RCA, DURING THE PROCEDURE PLAQUE PROLAPSE WAS NOTED AND THE PATIENT WAS TREATED WITH TWO MEDTRONIC STENTS IN THE RCA. THE PATIENT WAS STABLE AND DISCHARGED HOME.

  Patient problems: Injury; Stenosis

  MAUDE report 10656393 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVASCULARIZATION PROCEDURE ONE RESOLUTE INTEGRITY BMS AS IMPLANTED IN THE RCA. APPROXIMATELY 6.5 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM WORSENING CORONARY ARTERY DISEASE AND WAS TREATED WITH MEDICATION AND REVASCULARIZATION OF THE RCA.

  Patient problems: Injury; Stenosis

  MAUDE report 10656267 ↗
• InjuryJun 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT A SNARE WAS ATTEMPTED TO BE USED TO REMOVE THE DISLODGED STENT WITHOUT SUCCESS. A SECOND STENT WAS USED TO TRAP AND CRUSH THE STENT TO THE VESSEL WALL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 10183052 ↗
• MalfunctionJun 8, 2020Use of Device Problem; Use of Device Problem

  A RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A NONE TORTUOSITY, SEVERELY CALCIFIED LESION EXHIBITING 98-99% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A PATIENT EXPERIENCING SEVERE CHEST PAIN WITH DIAGNOSIS OF STEMI INFERIORLY WITH RECIPROCAL CHANGES WAS BROUGHT FROM ER TO THE CATH LAB FOR EVALUATION AND TREATMENT. A DIAGNOSTIC CORONARY ANGIOGRAPHY SHOWS 98-99% OCCLUDED RCA SECONDARY TO PLAQUE RUPTURE. A RESOLUTE INTEGRITY BARE METAL STENT WAS PLACED IN THE RIGHT CORONARY ARTERY WITH GOOD RESULTS AND PROMPT RESOLUTION OF SYMPTOMS. IT WAS REPORTED THAT THE PRODUCT WAS EXPIRED. THE EXPIRED PRODUCT WAS QUARANTINED WITHIN THE CATH LAB, HOWEVER WAS STILL ACCESSIBLE TO STAFF. STAFF PULLED AN EXPIRED BMS FROM QUARANTINED PILE FOR IMPLANT. NOTE, ROUTINE INVENTORY INSPECTION BY MDT REP HAVE BEEN RESTRICTED DUE TO COVID-19 ALLOWING NO ACCESS TO THE HOSPITAL STARTING MARCH 2020. THE PATIENT IS ALIV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10128159 ↗
• InjuryMay 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION LOCATED IN THE MID CIRCUMFLEX ARTERY. IT WAS REPORTED THAT A NON-MEDTRONIC GUIDE WIRE CROSSED THE LESION, HOWEVER THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED ON REMOVAL OF THE DEVICE FROM THE PATIENT. FLUOROSCOPY EXAMINATION SHOWED THE STENT DISLODGED IN THE COMMON FEMORAL ARTERY AREA CLOSE TO THE TIP OF THE FEMORAL SHEATH. THE STENT BECAME EMBOLIZED DOWNSTREAM OF THE FEMORAL ARTERY SYSTEM. IT WAS STATED THAT THE STENT IS LODGED IN THE DISTAL TIBIOPERONEAL TRUNK AND MOSTLY IN THE PERONEAL ARTERY AND EVIDENCE OF FLOW THROUGH ALL OUTFLOW VESSELS WAS OBSERVED. IT WAS STATED THAT THE PATIENT IS ASYMPTOMATIC. THERE IS NO EVIDENCE OF LIMB ISCHEMIA. IT WAS STATED THAT ATTEMPTS TO RETRIEVE THE DEVICE WOULD POTENTIALLY CAUSE MORE HARM WITH POSSIBLE VASCULAR INJURY. THE PATIENT WILL NEED LONG TERM SURVEILLANCE OF THE RIGHT LOWER EXTREMITY VESSELS.

  Patient problems: Injury

  MAUDE report 10078716 ↗
• MalfunctionMay 6, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING / ADVANCEMENT. IT WAS STATED THAT THE STENT FAILED TO CROSS THE LESION AND WAS REMOVED. UPON REINSERTION THE STENT WOULD NOT LOAD ONTO THE WIRE. THE STENT STRUTS WERE NO LONGER INTACT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10027912 ↗
• MalfunctionMay 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER SNAPPED IN 2 PIECES UPON ADVANCING THE DEVICE TO THE LESION. IT WAS STATED THAT THE STENT COULD NOT BE DEPLOYED AND ALL OF THE PRODUCT WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10027673 ↗
• MalfunctionApr 7, 2020Component Missing; Component Missing

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO INTEGRITY RX CORONARY STENT SYSTEMS TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICES PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE NOT INSPECTED BEFORE USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009829389. THE LESION WAS NOT PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009900545. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENTS MAY NOT HAVE BEEN ON THE CATHETER PRIOR TO USE. IT WAS STATED THAT THERE IS NO EVIDENCE OF THE STENTS IN THE VESSEL POST BALLOON INFLATION. IT WAS NOTED THAT SEVERAL OTHER INTEGRITY STENTS WERE PLACED AFTER THE FIRST TWO STENTS WERE ALLEGEDLY DEPLOYED AND THESE STENTS ARE VISIBLE IN THE VESSEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933138 ↗
• MalfunctionApr 7, 2020Component Missing; Component Missing

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO INTEGRITY RX CORONARY STENT SYSTEMS TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICES PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE NOT INSPECTED BEFORE USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009829389. THE LESION WAS NOT PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009900545. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENTS MAY NOT HAVE BEEN ON THE CATHETER PRIOR TO USE. IT WAS STATED THAT THERE IS NO EVIDENCE OF THE STENTS IN THE VESSEL POST BALLOON INFLATION. IT WAS NOTED THAT SEVERAL OTHER INTEGRITY STENTS WERE PLACED AFTER THE FIRST TWO STENTS WERE ALLEGEDLY DEPLOYED AND THESE STENTS ARE VISIBLE IN THE VESSEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933109 ↗
• MalfunctionFeb 12, 2020Use of Device Problem; Use of Device Problem

  ONE INTEGRITY RX CORONARY BARE METAL STENT WAS IMPLANTED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ONE MONTH AFTER THE EXPIRY DATE. THE DEVICE REMAINS IN THE PATIENT. NO INTERVENTION OR PATIENT INJURY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699184 ↗
• InjuryNov 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY BARE METAL STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION LOCATED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT DISLODGED IN THE LM DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS JAILED USING A NON MEDTRONIC PERIPHERAL STENT IN THE LEFT ILIAC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375668 ↗

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