PK Papyrus 4.5/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640130447301), received between Mar 23, 2020 and Feb 3, 2025 — classified as 2 deaths, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN ANEURYSM IN THE MID TO DISTAL RCA. IT WAS ATTEMPTED TO PLACE THE STENT WITHIN THE ANEURYSM, BUT IT DISLODGED FROM THE BALLOON. THE DISLODGED STENT WAS RETRIEVED. THE ANEURYSM WAS TREATED WITH OTHER PK PAPYRUS STENTS WITH GOOD RESULT. PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300451 ↗
• MalfunctionMar 18, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE PROXIMAL RCA. ON THE FIRST ATTEMPT, THE LESION COULD NOT BE CROSSED WITH THE DEVICE. FURTHER ATTEMPTS FOLLOWED, AND ON THE FOURTH INSERTION ATTEMPT, THE STENT DISLODGED FROM THE STENT SYSTEM. THEY WERE UNABLE TO RETRIEVE THE STENT, SO THE DISLODGED STENT WAS DEPLOYED IN THE PROXIMAL PORTION OF THE LESION. ANOTHER PK PAPYRUS WAS DEPLOYED IN OVERLAPPING MANNER IN THE MID PORTION, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923146 ↗
• MalfunctionJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS ATTEMPTED TO BE PLACED IN LEFT PROFUNDA AND BECAME DISLODGED UPON ENTRY IN THE LEFT BRACHIAL ARTERY. STENT WAS RETRIEVED WITH A SNARE WITHOUT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18558267 ↗
• MalfunctionSep 1, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023 A LESION WAS TREATED IN THE PROXIMAL LAD WITH A DES DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. THE PK PAPYRUS 4.5/26 WITH EXPIRY DATE 31-JUL-2023 WAS INTRODUCED INTO THE PATIENTS BODY. THE COVERED STENT WAS SUCCESSFULLY IMPLANTED, FOLLOWED BY IMPLANTATION OF ANOTHER PK PAPYRUS COVERED STENT WITH EXPIRY DATE 31-OCT-2023 IN AN OVERLAPPING MANNER. AFTER POST-DILATION THE LESION WAS SEALED SUCCESSFULLY. THE PATIENT WAS DISCHARGED HOME. THE PHYSICIAN DISCOVERED THAT THE 4.5/26 COVERED STENT HAD BEEN IMPLANTED AFTER ITS EXPIRY DATE ABOUT 15 MINUTES AFTER THE IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671455 ↗
• 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 16755721 ↗
• DeathJan 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. AFTER IMPLANTATION OF THE COVERED STENT THE PERFORATION WAS SUCCESSFULLY SEALED. THE PATIENT INITIALLY ACHIEVED HER HEMODYNAMICS, AND SHE WAS COMPLETELY OFF ANY PRESSORS/INOTROPES. SUBSEQUENTLY, SHE DEVELOPED PROFOUND CARDIOGENIC SHOCK. A REPEAT DIAGNOSTIC ANGIOGRAM SHOWED A TOTAL OCCLUSION OF THE LAD. PENUMBRA WAS USED TO EXTRACT THE INTRACORONARY THROMBUS AFTER RE-HEPARINIZING THE PATIENT, BUT IT WAS FUTILE. THE PATIENT EXPIRED.

  Patient problems: Cardiogenic Shock; Thrombosis/Thrombus

  MAUDE report 16134394 ↗
• MalfunctionMar 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER TREATING A LONG PSEUDOANEURYSM IN A SVG WITH A PK PAPYRUS COVERED STENT, A SECOND PK PAPYRUS STENT WAS SELECTED, BUT THE STENT SLID BACK ONTO THE DELIVERY SHAFT WHEN PASSING THE 7F GUIDELINER. ANOTHER PK PAPYRUS WAS USED TO COMPLETE THE INTERVENTION SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660588 ↗
• DeathMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION OF THE OSTIAL/PROXIMAL LCX. THE MECHANISM OF THE PERFORATION, ITS LENGTH AND THE REFERENCE VESSEL DIAMETER WERE NOT REPORTED. THE PERFORATION WAS INITIALLY TREATED WITH A BALLOON DILATION IN ORDER TO STOP THE BLEEDING. AFTERWARDS THE AFFECTED PKP WAS CHOSEN TO SEAL THE PERFORATION, BUT IT GOT CAUGHT AT A CALCIFICATION AND DISLODGED. AN ATTEMPT TO RETRIEVE THE STENT WAS NOT SUCCESSFUL. IN THE FURTHER COURSE OF THE PROCEDURE THE PATIENT WAS HEMODYNAMICALLY INSTABLE, WITH PERICARDIAL TAMPONADE, PERSISTING CARDIOGENIC SHOCK. PATIENT EXPIRED DUE TO CARDIAC ARREST. OUTCOME WAS RATED AS PROCEDURE RELATED COMPLICATION, NOT DEVICE RELATED.

  Patient problems: Cardiogenic Shock

  MAUDE report 11889544 ↗
• InjuryMar 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT WAS FOUND IN AN INTERNAL AUDIT. A PK PAPYRUS US COVERED STENT SYSTEM WAS USED TO TREAT A PERFORATION IN THE RCA. PERI-PROCEDURAL, THERE WAS AN ACUTE IN-STENT THROMBOSIS.

  Patient problems: Thrombus

  MAUDE report 9865117 ↗