PK Papyrus 4.5/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640130447196), received between Oct 29, 2019 and Nov 27, 2024 — classified as 2 deaths, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• DeathNov 27, 2024Fracture; Failure to Advance; Fracture; Failure to Advance

  DURING A COMPLEX PROCEDURE WITH RECANALIZATION OF DIFFUSE RCA DISEASE AND PLACEMENT OF 4 STENTS, A TYPE III PERFORATION OCCURRED IN THE DISTAL PART OF THE RCA CAUSED BY BALLOON DILATATION. PERICARDIOCENTESIS WAS PERFORMED (MILD PERICARDIAL EFFUSION). AFTER ATTEMPT OF BALLOON DILATATIONS THE PERFORATION WAS STILL PRESENT. THE PK PAPYRUS WAS SELECTED FOR TREATMENT, BUT THE STENT WOULD NOT ADVANCE, EVEN WITH USING A 6F GUIDELINER. WHEN REMOVING THE DEVICE, THERE WAS A FRACTURE OF THE SHAFT OF THE DELIVERY SYSTEM NOTICED PROXIMAL TO THE STENT. ANOTHER PK PAPYRUS WAS IMPLANTED IT AT THE PERFORATION SITE, WHICH SUCCESSFULLY CONTAINED THE PERFORATION. LATER THE SAME DAY, THE PATIENT PASSED AWAY. THE PHYSICIAN STATED THAT THE DEATH IS NOT A DEVICE OR PROCEDURE RELATED COMPLICATION.

  Patient problems: Cardiogenic Shock

  MAUDE report 20797451 ↗
• MalfunctionSep 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS (PKP) COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE PROXIMAL LAD. IT TOOK SEVERAL PAPYRUS STENTS TO SEAL THE PERFORATION AND TOOK ATTENTION TO NOT PUT A PAPYRUS OVER THE ORIGIN OF THE CIRCUMFLEX. TWO PKPS WERE SUCCESSFULLY IMPLANTED. THE THIRD 4.5X15 PKP STENT WAS USED AND OBSERVED TO BE SLIPPING OFF THE BALLOON CATHETER. THE STENT WAS PULLED BACK INTO THE GUIDE AND DEPLOYED INSIDE THE GUIDE CATHETER TO MAKE SURE THERE WAS NO STENT MIGRATION. THE GUIDE CATHETER WAS THEN REMOVED AND SO THE STENT WAS SUCCESSFULLY REMOVED FROM THE BODY. IT WAS OBSERVED THAT THE PERFORATION APPEARED TO BE SEALED AND IT WAS DECIDED THAT AN ADDITIONAL PKP WAS NO LONGER NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128279 ↗
• InjuryJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE PROXIMAL LAD. THE LESION WAS PREPARED WITH BOTH A BALLOON AND A SHOCKWAVE BALLOON. A DES STENT WAS IMPLANTED AND POST-DILATED WITH A NC BALLOON DURING WHICH A CORONARY ARTERY PERFORATION OCCURRED. PERICARDIAL TAMPONADE WAS ENSUED DUE TO RAPID BLEEDING INTO THE PERICARDIUM, AND EMERGENT PERICARDIOCENTESIS WAS PERFORMED BY IMPLANTATION OF A PK PAPYRUS 4.0/15 AT THE DISTAL END OF THE PREVIOUSLY IMPLANTED STENT, BUT IT DID NOT COVER THE LAD PERFORATION. THE PATIENT DEVELOPED CARDIOGENIC SHOCK REQUIRING EMERGENT INTUBATION AND INITIATION OF THREE VASOPRESSORS. THE COMPLAINT PK PAPYRUS WAS INTRODUCED INTO THE PATIENTS BODY, BUT THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS SNARED SUCCESSFULLY. ALSO, A PK PAPYRUS US 3.5/15 WAS INTRODUCED INTO THE PATIENTS BODY BUT AGAIN THE STENT DISLODGED FROM THE BALLOON (REPORTED SEPARATELY). THE DISLODGED STENT WAS THEN REMOVED FROM THE PATIENTS BODY BY USE OF A BALLOON. EVENTUALLY, THE PERFORATION EVENTUALLY RESOLVED ON ITS OWN. THE TARGET VESSEL WAS AGAIN DILATED WITH A BALLOON AND ANOTHER DES STENT WAS IMPLANTED. HOWEVER, THE PATIENT WAS IN CARDIOGENIC SHOCK AND W

  Patient problems: Cardiogenic Shock

  MAUDE report 17415932 ↗
• DeathJul 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR THE TREATMENT OF A CORONARY ARTERY PERFORATION IN THE MID RCA. UNFORTUNATELY, THE COVERED STENT GOT SEPARATED FROM THE DELIVERY SYSTEM IN THE OSTIAL RCA (UNDEPLOYED). IT WAS POSSIBLE TO MOVE IT TO THE DESIRED LOCATION WITH THE DELIVERY SYSTEM, AND ALSO ABLE TO DEPLOY IT BY REINSERTING THE DELIVERY BALLOON BACK INTO PKP AND INFLATING AS USUAL.

  Patient problems: Cardiac Arrest

  MAUDE report 17379519 ↗
• MalfunctionJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION IN THE MID RCA. THE PK PAPYRUS STENT WAS NOT DEPLOYED AS IT DISLODGED FROM THE BALLOON. HOWEVER, IT IS NOT SURE IF THE DISLODGEMENT OCCURRED INSIDE OR OUTSIDE OF THE PATIENTS BODY. THE PERFORATION WAS SEALED BY IMPLANTING TWO OTHER PK PAPYRUS STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075206 ↗
• MalfunctionApr 17, 2023Lack of Effect; Lack of Effect

  THE PK PAPYRUS 4.5/26 COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE LEFT MAIN. THE STENT DID NOT SEAL AND LEAKED AFTER PLACEMENT. AN ADDITIONAL PK PAPYRUS 4.25/15 STENT WAS IMPLANTED, SLIGHT IMPROVEMENT BUT CONTINUED PERFORATION. THEN, LONG BALLOON INFLATION (2 AND 5 MIN.) WAS PERFORMED, AND THE PERFORATION APPEARED TO BE SEALED. BEDSIDE ECHO WAS PERFORMED CONFIRMING MODERATE EFFUSION AN RV COMPRESSION. DRAIN WAS PLACED. PATIENT IS NO SURGICAL CANDIDATE DUE TO LOW PLATELETS AND OTHER FACTORS. PATIENT WAS STABLE AT THE END AND DISCHARGED ON(B)(6) 2023. THE TWO STENTS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755726 ↗
• MalfunctionMar 7, 2023Lack of Effect; Lack of Effect

  TWO PK PAPYRUS COVERED STENTS WERE USED TO TRY TO SEAL A TYPE III PERFORATION IN THE PROXIMAL LAD, BUT WERE UNSUCCESSFUL. THE OTHER STENT IS FILED SEPARATELY.

  Patient problems: Insufficient Information

  MAUDE report 16497518 ↗
• MalfunctionOct 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CORONARY ANGIOGRAPHY WAS PERFORMED INCLUDING USING A SHOCKWAVE BALLOON. THE ANGIOGRAM SHOWED A PERFORATION OF THE VESSEL AT THE SITE OF THE SHOCKWAVE THERAPY. THEY TRIED TO SEAL THE PERFORATION BY USING A PK PAPYRUS COVERED STENT SYSTEM BUT THIS COULD NOT BE DELIVERED, AND THE STENT WAS LOST. THE STENT COULD NOT BE LOCATED WITHIN THE BODY AND ANOTHER STENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670857 ↗
• MalfunctionFeb 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR THE TREATMENT OF A PERFORATION IN THE RCA. IT WAS ATTEMPTED TO PLACE THE PK PAPYRUS IN THE DISTAL RCA BUT IT DISLODGED FROM THE BALLOON AND HAD TO BE DEPLOYED IN THE PROXIMAL RCA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379806 ↗
• MalfunctionOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PK PAPYRUS 4.5/15 WAS SELECTED FOR TREATMENT OF A 5MM PERFORATION IN THE MAIN BRANCH OF THE RCA.THE STENT DISLODGED FROM BALLOON IN THE GUIDEZILLA EXTENSION CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251557 ↗