PK Papyrus 5.0/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130447202), received between Jul 13, 2020 and Sep 19, 2024 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE MAIN BRANCH OF THE LAD. THE STENT DISLODGED FROM DELIVERY BALLOON. IT WAS ADAPTED TO THE VESSEL WALL WITH ANOTHER PK PAPYRUS. THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260944 ↗
• InjuryOct 25, 2022Lack of Effect

  A CORONARY ANGIOGRAPHY WAS PERFORMED INCLUDING USING A SHOCKWAVE BALLOON IN A SVG. THE ANGIOGRAM SHOWED A PERFORATION IN THE VENOUS GRAFT AT THE SITE OF THE SHOCKWAVE THERAPY. AN ATTEMPT WAS MADE TO SEAL THE PERFORATION WITH A PK PAPYRUS COVERED STENT SYSTEM, BUT IT COULD NOT BE DELIVERED AND THE STENT WAS LOST (REPORTED SEPARATELY). THE COMPLAINT PK PAPYRUS DEVICE WAS DEPLOYED BUT COULD NOT SEAL THE 12MM LONG PERFORATION COMPLETELY. THE PATIENT CONDITION DETERIORATED, A THROMBUS WAS DETECTED AS PROCEDURE RELATED COMPLICATION AND SURGERY WAS DISCUSSED BUT IN VIEW OF PATIENTS HISTORY IT WAS DECIDED AGAINST IT. PATIENT WAS SHIFTED TO CCU. DEVICE CODE IS (B)(4).

  Patient problems: Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 15670627 ↗
• DeathOct 18, 2022Adverse Event Without Identified Device or Use Problem

  TWO PK PAPYRUS COVERED STENTS WERE USED FOR TREATMENT OF A TYPE III PERFORATION IN THE LEFT MAIN, BUT WITH INCOMPLETE SEALING. THERE WAS PERICARDIAL TAMPONADE WITH ONGOING BLEEDING. PATIENT EXPIRED. THE EVENT WAS DESCRIBED BY THE PHYSICIAN AS NOT DEVICE OR PROCEDURE RELATED. THE OTHER PK PAPYRUS IS FILED SEPARATELY. (B)(4).

  Patient problems: Cardiac Tamponade; Myocardial Infarction

  MAUDE report 15626458 ↗
• InjuryJul 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER TREATMENT OF A LESION WITH ATHERECTOMY, BALLOON DILATATION AND PLACEMENT OF A DES IN THE MID RCA, A PERFORATION WAS DETECTED. 3 PK PAPYRUS STENTS WERE IMPLANTED. FOR TWO HOURS THE PATIENT WAS STABLE BUT JUST BEFORE TRANSFERRING THE PATIENT TO CCU, EXTRAVASATION FROM PERICARDIAL SPACE WAS NOTICED. ANOTHER PK PAPYRUS STENT (COMPLAINT DEVICE) WAS ADVANCED TO THE PROXIMAL RCA, BUT THE STENT DISLODGED. THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND WAS THEREFORE TRANSFERRED TO OPERATING ROOM. AN EMERGENT STERNOTOMY WAS PERFORMED. AN APPROX. 0.5 INCH TEAR WAS NOTICED AT THE RV-RA JUNCTION. PATIENT HAD SVG TO PDA AND DIRECT REPAIR OF THE RCA TO RV TEAR.

  Patient problems: Pericardial Effusion

  MAUDE report 15015365 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PK PAPYRUS US COVERED STENT SYSTEM WAS CHOSEN TO SEAL A VERY LARGE PERFORATION. THE PERFORATION WHICH OCCURRED ON A GIANT PIECE OF CALCIUM HIT WITH A ROTABLATOR WAS IN THE PROXIMAL LAD IN A VESSEL THAT IS OCCLUDED MID LAD AND IN A DIAGONAL, SUPPLYING MANY SEPTALS OF THE RCA TO SEAL THE PERFORATION BIFURCATION STENTING WAS DONE, BUT THE LAD PERFORATION WAS NOT FULLY COVERED BY THE 2ND PK PAPYRUS PLACED FROM LM INTO THE LAD. THEREFORE 3RD WAS PLACED LEFT MAIN INTO CX. DUE TO COVERING THE LAD WHICH WAS NECESSARY TO SEAL AND SURVIVE THE PERFORATION THE PATIENT HAD A PROCEDURAL MYOCARDIAL INFARCTION. ALL THREE PK PAPYRUS US STENTS WERE PROPERLY DEPLOYED. THERE WAS NO MALFUNCTION OF THE DEVICE. IT IS NOT KNOWN WHICH OF THE THREE PLACED PK PAPYRUS US, WHICH HAD TO BE PLACED DURING THE INTERVENTION TO SAVE THE PATIENTS LIFE, POSSIBLY LED TO PROCEDURAL MYOCARDIAL INFARCTION. 3 STENTS REPORTED ON MDR-1028232-2020-02866, MDR-1028232-2020-02867, AND MDR-1028232-2020-02868.

  Patient problems: Myocardial Infarction

  MAUDE report 10268193 ↗