Resolute Onyx™ RONYX27512UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169556881), received between Sep 14, 2017 and Aug 2, 2022 — classified as 1 death, 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED TO TREAT A NON CALCIFIED, NON TORTUOUS LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND RIGHT POSTERIOR DESCENDING (R-PDA) ARTERY. THE PATIENT HAD A ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND WAS BEING TREATED FOR HEART ATTACK. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT AN INCORRECT STENT SIZE WAS FOUND TO BE IN THE PACKAGE. THE ACCOUNT OPENED A 2.75 X 12MM STENT PACKAGE BUT INSIDE THERE WAS A 2.75 X 15MM LENGTH STENT. THE ISSUE WAS NOTICED WHEN THE STENT WAS IN THE BODY READY TO BE DEPLOYED. THE STENT WAS DEPLOYED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146666 ↗
• MalfunctionJul 19, 2022Defective Component; Material Deformation; Defective Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. IT WAS DETAILED THAT AFTER DEPLOYMENT THE LENGTH OF THE STENT IN THE VESSEL WAS 15MM AND NOT 12MM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052006 ↗
• InjuryMay 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE OSTIUM RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DETAILED THAT THE STENT WAS DEPLOYED WHERE IT CAME OFF THE BALLOON. THE STENT REMAINS IMPLANTED IN THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14539588 ↗
• MalfunctionFeb 18, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 98% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PHYSICIAN NOTED THAT THE STENT APPEARED DEFORMED WHEN CROSSING THE LESION SO THE DEVICE WAS THEN REMOVED BACK TO THE SHEATH. IT WAS ALSO REPORTED THAT THE STENT CAME OFF THE BALLOON OUTSIDE THE BODY POST PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13558167 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE GRAFT 2ND OBTUSE MARGINAL. TWO DAYS AFTER INDEX PROCEDURE, THE PATIENT UNDERWENT A STAGED PROCEDURE AND THREE RESOLUTE ONYX DES WERE IMPLANTED, TWO IN THE RAMUS AND ONE IN THE LEFT MAIN CORONARY ARTERY. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED FROM MYOCARDIAL INFARCTION (NON-TARGET VESSEL). IT IS REPORTED THAT NO TARGET (INDEX PROCEDURE) VESSEL(S) WERE INVOLVED, BUT THE SPECIFIC VESSEL FOR MI INVOLVEMENT IS NOT REPORTED. THE EVENT WAS TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 12133345 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG-ELUTING STENTS IMPLANTED IN THE LAD. A DISSECTION OCCURRED DURING PROCEDURE. APPROXIMATELY 19 MONTHS POST PROCEDURE, PATIENT SUFFERED GASTROINTESTINAL BLEED AND WAS HOSPITALIZED. PATIENT WAS ON DAPT WITHIN 24 HOURS PRIOR TO EVENT. INVESTIGATOR ASSESSED EVENT AS NOT RELATED TO THE STUDY DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS NOT RELATED TO STUDY DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10980079 ↗
• MalfunctionOct 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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 A FAILED DELIVERY. IT WAS STATED THAT UPON PULLING BACK THE STENT INTO THE GUIDE, THE DISLODGEMENT WAS NOTED BUT THE STENT WAS STILL PARTIALLY ON THE DELIVERY SYSTEM. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT THE STENT COULD NOT BE FOUND. THE GUIDE WAS REMOVED AND FLUSHED BUT THE STENT WAS NOT LOCATED. IT WAS STATED THAT THE STENT WAS NOT RETRIEVED AND THERE WAS NO INTERVENTION CARRIED OUT AS THE STENT WAS NOT IDENTIFIED WITHIN THE PATIENTS BODY. IT IS BELIEVED THE STENT IS STILL IN THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10761546 ↗
• DeathJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE 2ND OBTUSE MARGINAL. TWO DAYS LATER DURING A STAGED PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED; TWO IN THE RAMUS AND ONE IN THE LCMA. APPROXIMATELY 20 MONTHS LATER, THE PATIENT SUFFERED CARDIOGENIC SHOCK, SEVERE MITRAL REGURGITATION, WORSENING RENAL FAILURE AND DIED. DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10127351 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. DURING THE PROCEDURE SIDE BRANCH OF PARENT TARGET VESSEL WAS JAILED AND THE PATIENT EXPERIENCED CHEST PAIN. AN MI OCCURRED IN THE LAD SECONDARY TO SIDE BRANCH LOSS. THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT RECOVERED. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE OR ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THAT THE EVENT IS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE ANTI PLATELETS.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 8572301 ↗
• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE WAS PROMPTED BY UNSTABLE ANGINA. DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 3 WEEKS POST PROCEDURE THE PATIENT SUFFERED GI BLEED. PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. THE EVENT WAS TREATED WITH MEDICATION AND BLOOD TRANSFUSION. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 8389493 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE LAD AND THREE RESOLUTE ONYX STENT WERE IMPLANTED INTO THE LCX. ONE DAY POST PROCEDURE THE PATIENTS CARDIAC ENZYMES WERE ELEVATED. CEC ASSESSED THE EVENT AS NON Q WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI PCI. CEC ALSO ASSESSED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8372958 ↗
• MalfunctionJul 12, 2018Difficult or Delayed Positioning; Device Dislodged or Dislocated; Material Deformation; Difficult or Delayed Positioning

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE LEFT MAIN OF A PATIENT. IT WAS REPORTED THAT THE STENT BECAME DEFORMED AND DISLODGED DURING POSITIONING, WHEN DELIVERING TO THE LESION. THE STENT REMAINED ON THE WIRE AND WAS RETRACTED ON THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED FOR THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 7680931 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A TOTAL OF THREE RESOLUTE ONYX DRUG ELUTING STENT WERE USED TO TREAT A NON- TORTUOUS AND MODERATELY CALCIFIED LESION, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESIONS WERE PRE-DILATED. 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. ONE 2.75X12MM RESOLUTE ONYX WAS IMPLANTED AT THE OSTIUM OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18ATM. THE STENT WAS POST DILATED TO 20 ATM. ONE 2.75X8MM RESOLUTE ONYX WAS IMPLANTED AT THE OSTIUM OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18ATM. THE STENT WAS POST DILATED TO 18ATM. ONE 2.75X12MM RESOLUTE ONYX WAS IMPLANTED IN THE PROXIMAL SUBSECTION OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18ATM. THE BALLOON OF THE 2.75X8MM RESOLUTE ONYX, AND A NON-MEDTRONIC BALLOON WERE USED TO POST DILATE

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7556751 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A TOTAL OF THREE RESOLUTE ONYX DRUG ELUTING STENT WERE USED TO TREAT A NON- TORTUOUS AND MODERATELY CALCIFIED LESION, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESIONS WERE PRE-DILATED. 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. ONE 2.75 X 12 MM RESOLUTE ONYX WAS IMPLANTED AT THE OSTIUM OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18 ATM. THE STENT WAS POST DILATED TO 20 ATM. ONE 2.75 X 8 MM RESOLUTE ONYX WAS IMPLANTED AT THE OSTIUM OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18 ATM. THE STENT WAS POST DILATED TO 18 ATM. ONE 2.75 X 12 MM RESOLUTE ONYX WAS IMPLANTED IN THE PROXIMAL SUBSECTION OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18 ATM. THE BALLOON OF THE 2.75 X 8 MM RESOLUTE ONYX, AND A NON-MEDTRONIC BALLOON WERE USE

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7556734 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THE DISTAL RCA WAS TREATED WITH ONE RESOLUTE ONYX DRUG ELUTING STENT. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A GI BLEED. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY AT THE TIME OF THE EVENT. THE PATIENT WAS TREATED WITH UPPER ENDOSCOPY, COLONOSCOPY, BLOOD TRANSFUSION AND MEDICATION. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE INDEX DEVICE BUT PROBABLY RELATED TO ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 7376735 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE RESOLUTE ONYX DES WERE USED TO TREAT THE PROXIMAL, MIDDLE AND DISTAL RCA AND THE RIGHT POSTERIOR DESCENDING LATERAL ((B)(6) 2017). APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED AN ACUTE CVA ((B)(6) 2017).

  Patient problems: Stroke/CVA

  MAUDE report 7166980 ↗
• InjuryDec 13, 2017Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED FOUR RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE DISTAL CIRCUMFLEX ARTERY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE LOT # 0008761275 WAS NOT INSPECTED. THE OTHER THREE DEVICES (LOT # 0008558962, 0008682478 AND 0008581806) WERE INSPECTED WITH NO ISSUES IDENTIFIED, THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE PATIENT HAD A CLINICAL ADVERSE EVENT OF AN ACUTE (0-24 HOURS POST STENT IMPLANTATION) STENT THROMBOSIS. ANGIOGRAPHY WAS PERFORMED ON LEFT CORONARY SYSTEM AND IDENTIFIED LESIONS IN THE CX. A WIRE WAS PASSED AND LESION WAS PRE-DILATED DISTALLY AND PROXIMALLY WITH A BALLOON. IT WAS DESCRIBED THAT THE PHYSICIAN NOTICED SLUGGISH FLOW AND STENTED DISTAL AND PROXIMAL SEGMENT OF THE CX. SLOW FLOW WAS NOTICED. IVUS WAS USED SEVERAL TIMES TO AS

  Patient problems: Thrombus

  MAUDE report 7111912 ↗
• MalfunctionOct 3, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LAD. THE LESION WAS PRE-DILATED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT IS REPORTED THAT STENT DEFORMATION OCCURRED DURING REMOVAL FROM THE PATIENT FOLLOWING ATTEMPTED DELIVERY TO THE LESION. ON INSPECTION IT WAS NOTED THAT THE STRUTS WERE POKING UP. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6910066 ↗
• MalfunctionSep 14, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT (2.75X12MM) TO TREAT A LESION IN THE RCA. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM PACKAGING. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT IS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND A STRUT LIFTED WHILE ATTEMPTING TO CROSS THE LESION. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, NO FORCE WAS APPLIED. THE PROCEDURE WAS COMPLETED USING A 2.75 X 8MM NON-MEDTRONIC STENT. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6864122 ↗