Promus PREMIER™ H7493952832350Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729844983), received between Jul 18, 2017 and Jun 20, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Bent” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CHEST DISCOMFORT AND SHORTNESS OF BREATHING ISSUES OCCURRED. A PATIENT WITH A PREVIOUSLY IMPLANTED 3.50 X 32 MM PROMUS PREMIER¿ STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY AND A NON BSC PACEMAKER UNDERWENT MAGNETIC RESONANCE IMAGING (MRI) SCANS OF THE RIGHT AND LEFT KNEE. THE PACEMAKER WAS SET TO 70 BEATS PER MINUTE AND IN MR MODE. DURING THE FIRST SCAN OF THE RIGHT KNEE, HOSPITAL STAFF POSITIONED THE OXYGEN SATURATION PROBE ON THE PATIENT'S LEFT HAND AND PLACED THE LEFT HAND OVER THE PATIENT'S CHEST IN THE VICINITY OF THE HEART AND PACEMAKER AND THE PATIENT EXPERIENCED SIGNIFICANT CHEST DISCOMFORT AND BREATHING ISSUES. THE ATTENDING STAFF NOTED THAT DURING THE SCANS, EPISODES OF OXYGEN SATURATION (SPO2) LOSS OCCURRED. DURING THE SECOND MRI SCAN OF THE LEFT KNEE THE SPO2 PROBE WAS LOCATED AT THE LEFT SIDE OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY CHEST DISCOMFORT OR BREATHING ISSUES AND THERE WAS NO LOSS OF OXYGEN SATURATION. THE PATIENT IMPACT WAS TRANSIENT AND PATIENT RECOVERED WHEN STIMULUS WAS REMOVED.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 7619411 ↗
• InjuryOct 25, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS FURTHER REPORTED THAT ANGIOGRAPHY WAS PERFORMED WHICH LED TO THE DISCOVERY OF THROMBOSIS. A NON-BSC STENT WAS DEPLOYED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND ANOTHER PROMUS STENT WAS DEPLOYED IN THE DIAGONAL BRANCH. THE INTERVENTION WAS SUCCESSFUL AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Thrombosis

  MAUDE report 6976354 ↗
• MalfunctionOct 16, 2017Break; Difficult to Remove; Device Damaged by Another Device; Break; Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT CATHETER WITHDRAWAL DIFFICULTIES WERE ENCOUNTERED AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 3.50X32MM PROMUS PREMIER DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. AFTER THE STENT WAS SUCCESSFULLY DEPLOYED, THERE WAS SOME TENSION ON THE STENT DELIVERY SYSTEM (SDS). DURING REMOVAL, DIFFICULTIES WERE ENCOUNTERED AS THE DELIVERY CATHETER HAD BEEN SNAGGED ON THE PROXIMAL STENT STRUTS FROM A PREVIOUS PERCUTANEOUS CORONARY INTERVENTION (PCI). THE COMBINATION OF TORTUOUS ANATOMY AND HEAVY CALCIUM IN THE MID RCA CONTRIBUTED TO THE ISSUE AND FRAGMENTED A SEGMENT OF THE SDS. THE SDS AND THE FRAGMENTED SEGMENT WERE SUCCESSFULLY RETRIEVED IN THE GUIDE CATHETER. THE GUIDE CATHETER, GUIDE WIRE, THE SDS AND THE FRAGMENTED SEGMENT WERE REMOVED SUCCESSFULLY AS A UNIT WITHOUT ISSUES. NOTHING WAS LEFT INSIDE THE BODY. THE PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6951947 ↗
• MalfunctionJul 18, 2017Bent; Bent

  SAME CASE AS MDR ID# 2134265-2017-07127. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 1.25MM ROTALINK¿ PLUS WAS ADVANCED TO PERFORM ABLATION. THE DEVICE WAS ABLE TO DO TWO PASSES; HOWEVER, ON THE THIRD PASS, THE DEVICE KEPT STALLING. THE PHYSICIAN CHECKED ALL THE CONNECTIONS, INCLUDING THE DRIP AND EVERYTHING WAS FINE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS NOTED THAT THE METAL SHEATH THAT COVERS THE SPRING ON THE ROTABLATOR WAS TORN. ABLATION WAS COMPLETED WITH A 1.5MM ROTALINK¿ PLUS. FOLLOWING ABLATION, A 3.50X32MM PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED WITH A NON-BSC GUIDE EXTENSION CATHETER IN PLACE AND TWO GUIDE WIRES ACROSS THE LESION. HOWEVER, THE DEVICE COULD NOT PASS THROUGH THE NON-BSC GUIDE EXTENSION CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE STENT WAS NOTED TO BE SHREDDED UP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6722660 ↗