PK Papyrus 3.0/20/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07640130447226), received between Jul 1, 2019 and Aug 28, 2026 — classified as 9 deaths, 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• DeathAug 28, 2026Patient Device Interaction Problem

  The patient had severe underlying cardiovascular disease, including multivessel coronary artery disease and reduced left ventricular function. During PCI of the mid to distal LAD, a Type III coronary perforation was reported after DES placement. The perforation was treated with two PK Papyrus covered stents and was reported to have been successfully sealed. During the same procedure, acute thrombosis/occlusion of both PK Papyrus stents was reported, resulting in no-reflow and ventricular tachycardia/cardiac arrest. Following further intervention, final angiography reportedly showed TIMI 3 flow. The patient subsequently developed refractory shock and died later the same day. The cause of the acute stent thrombosis/occlusion and its potential contribution to the patient's death are under investigation. This report pertains to one of two PK Papyrus devices used during the same procedure involving the same patient and clinical event. Since it could not be determined if only one or both PKPs occluded, the second device is reported separately under manufacturer report number 8043892-2026-08115.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50492892 ↗
• DeathMay 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION (15 MM LENGTH) OCCURRED DURING POST-DILATATION OF A DES. AFTER THE FIRST PK PAPYRUS WAS PLACED, THE PERFORATION WAS NOT COMPLETELY SEALED (REPORTED SEPARATELY), SO A SECOND PK PAPYRUS WAS DEPLOYED (3.0/20, COMPLAINT DEVICE). A POSSIBLE EDGE DISSECTION AT THE EDGE OF THE SECOND STENT SUSPECTED, SO AN ONYX FRONTIER WAS DEPLOYED. AFTERWARDS, AN IMPELLA WAS PLACED AND THE PATIENT LEFT CATH LAB TO ICU. PATIENT CONTINUED TO HAVE SEVERE HEMODYNAMIC COMPROMISE DESPITE INCREASING MECHANICAL SUPPORT. FAMILY ULTIMATELY DECIDED TO WITHDRAW CARE.

  Patient problems: Hypoxia; Irregular Pulse; Vascular Dissection

  MAUDE report 22044293 ↗
• DeathJun 17, 2024Material Deformation; Material Deformation

  THE PROCEDURE WAS REPORTED AS AN EXTREMELY COMPLEX CASE WITH A TOTAL DURATION OF MORE THAN EIGHT HOURS. AFTER THE PLACEMENT OF AN IMPELLA, AN ATTEMPT WAS MADE TO PRESERVE THE LAD TO D1 BIFURCATION. NUMEROUS CONVENTIONAL AND SPECIALIZED WIRES AS WELL AS DIRECTED MICRO AND TWIN CATHETERS WERE USED TO CROSS THE SEVERELY CALCIFIED AND ANGULATED LESION AT THE OSTIUM OF D1 WITHOUT SUCCESS. DURING THE SUBSEQUENT STENTING OF THE MID LAD TO LMCA, A CORONARY ARTERY PERFORATION TYPE III OCCURRED. THE AFFECTED DEVICE WAS INTRODUCED, BUT THE STENT BECAME DEFORMED. TWO OTHER PK PAPYRUS (3.0/15) WERE IMPLANTED IN AN OVERLAPPING MANNER WHICH SUCCESSFULLY SEALED THE PERFORATION AFTER POST-DILATION. AFTER THE PROCEDURE THE PATIENT WAS TRANSFERRED TO THE ICU. ON THE SAME DAY HE DEVELOPED INCESSANT VENTRICULAR TACHYCARDIA AND SUBSEQUENTLY PULSELESS ELECTRICAL ACTIVITY. DESPITE VALIANT AND PROLONGED EFFORTS AT RESUSCITATION, THE PATIENT PASSED AWAY DUE TO CARDIOGENIC SHOCK AND PEA ARREST. THE TREATING PHYSICIAN RATED THE OUTCOME AS BOTH NO DEVICE- AND NO PROCEDURE-RELATED COMPLICATION.

  Patient problems: Cardiac Arrest; Cardiogenic Shock

  MAUDE report 19547274 ↗
• DeathAug 28, 2023Lack of Effect; Lack of Effect

  THE INTENTION WAS TO TREAT A LESION IN THE PROXIMAL LCX BY ROTABLATION DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. TO STOP THE BLEEDING BALLOON DILATION WAS PERFORMED. THE COMPLAINT PK PAPYRUS US 3.0/20 WAS INTRODUCED INTO THE PATIENTS BODY AND INFLATED WITH 8 ATM. HOWEVER, THE PERFORATION WAS NOT SEALED SUCCESSFULLY. THEREFORE, BOTH A DRUG ELUTING STENT AND A PK PAPYRUS US 4.0/15 WERE IMPLANTED, BUT STILL THE PERFORATION COULD NOT BE SEALED, DESPITE POST-DILATION WITH TWO BALLOONS (REPORTED SEPARATELY). THEREAFTER, THE PATIENT UNDERWENT AN EMERGENT CABG AND PASSED AWAY DUE TO HEMORRHAGIC SHOCK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 17638698 ↗
• DeathJun 19, 2023Use of Device Problem; Use of Device Problem

  THE PK PAPYRUS WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE MID LAD. THE PERFORATION WAS SEALED. THERE IS NO KNOWN COMPLAINT ON THIS DEVICE, BUT IT WAS IMPLANTED AFTER THE EXPIRATION DATE OF 31-MAR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152824 ↗
• DeathApr 13, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF TYPE II PERFORATION IN AN SVG. THE PK PAPYRUS STENT (COMPLAINT DEVICE) WAS DEPLOYED BUT COULD NOT SEAL THE PERFORATION IN THE VENOUS GRAFT. ANOTHER PK PAPYRUS STENT WAS USED BUT COULD NOT SEAL THE PERFORATION EITHER (REPORTED SEPARATELY). THE PATIENT WAS STABLE WHEN LEAVING THE LAB BUT DIED AFTER THE INTERVENTION ON THE SAME DAY DUE TO A MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK.

  Patient problems: Cardiogenic Shock; Myocardial Infarction

  MAUDE report 16736661 ↗
• MalfunctionApr 12, 2023Lack of Effect; Lack of Effect

  THE PK PAPYRUS COVERED STENT WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID TO DISTAL LAD. THIS ONE HAD INCOMPLETE SEALING/LEAKAGE. A SECOND PK PAPYRUS STENT WAS IMPLANTED AND SUCCESSFULLY SEALED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724984 ↗
• MalfunctionMar 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING ROTABLATION OF A LESION IN THE PROXIMAL LCX A TYPE II PERFORATION HAD OCCURRED. THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT, BUT THE STENT STRIPPED OFF THE BALLOON IN THE GUIDEZILA EXTENSION CATHETER. ANOTHER PK PAPYRUS STENT WAS IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497504 ↗
• MalfunctionSep 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MULTIPLE PASSES WITH ROTAPRO (ROTATIONAL ATHERECTOMY) DUE TO CALCIFICATION, LEAD TO TYPE III PERFORATION OF PROXIMAL LAD. THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PERFORATION. INITIALLY, TRIED A BLOCK AND DELIVER TECHNIQUE (PLACED A SECOND WIRE, BMW) INTO THE DISTAL LAD, AND OVER THIS TRIED TO DELIVER THE PK PAPYRUS, BUT THIS STRIPPED OFF. EVENTUALLY, IT WAS POSSIBLE TO RETRIEVE THE STENT. LOT EXPIRED 1Y 5M BEFORE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372673 ↗
• DeathAug 16, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UPON BALLOON ANGIOPLASTY, IN PREPARATION TO PROCEED WITH POSSIBLE STENT PLACEMENT, THE PATIENT HAD A TYPE III CS/IV PERFORATION IN THE PROXIMAL LCX, WHICH COULD NOT BE SUCCESSFULLY SEALED WITH TWO PK PAPYRUS COVERED STENTS (THE SECOND STENT IS REPORTED SEPARATELY). EVENTUALLY, THE PATIENT NEEDED A CT SURGERY WITH AN EMERGENT STERNOTOMY BUT THE PATIENT PASSED AWAY BUT AS STATED BY THE HOSPITAL, UNRELATED TO THE DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 15233828 ↗
• MalfunctionJul 5, 2022Failure to Advance; Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF TYPE III PERFORATION IN THE MID RCA. THE PK PAPYRUS 3.0/20 COULD NOT PASS THROUGH A 6F GUIDING CATHETER. ANOTHER PK PAPYRUS 2.5/15 COULD NOT PASS THE LESION (EVENT REPORTED SEPARATELY). A THIRD PK PAPYRUS STENT WAS IMPLANTED WHICH SEALED THE PERFORATION SUCCESSFULLY. THE PATIENT WAS HEMODYNAMICALLY STABLE. TWO DAYS AFTER THE INTERVENTION THE PATIENT DECEASED DUE TO MULTISYSTEM ORGAN FAILURE, NOT RELATED TO THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 14919705 ↗
• MalfunctionJun 6, 2022Inflation Problem; Inflation Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A TYPE III PERFORATION OCCURRED DURING ROTABLATOR IN THE MID RCA. AFTER DEVICE INTRODUCTION IT WAS NOT POSSIBLE TO DEPLOY THE STENT. THE DEVICE WAS REMOVED INTACT FROM THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605249 ↗
• InjuryMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING ATTEMPT TO IMPLANT A DES A TYPE II PERFORATION HAS OCCURRED IN THE LAD. AFTER UNSUCCESSFUL BALLOON DILATATION TO STOP THE BLEEDING, A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT, BUT WAS STRIPPED OFF FROM DELIVERY SYSTEM (FILED SEPARATELY). NO LESION DETAILS WERE PROVIDED. THE SECOND PK PAPYRUS WAS USED BUT WAS ALSO STRIPPED OFF. PERICARDIAL TAMPONADE HAD OCCURRED AND INSERTION OF PERICARDIAL DRAIN WAS REQUIRED. PATIENT WAS DISCHARGED HOME (B)(6) 2022.

  Patient problems: Cardiac Tamponade

  MAUDE report 13703611 ↗
• MalfunctionDec 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING TREATMENT OF A TOTAL OCCLUSION IN THE RIGHT PDA WITH A DES, A DISSECTION AND A TYPE III PERFORATION HAD OCCURRED, WHICH WAS INITIALLY TREATED WITH HIGH PRESSURE BALLOON FOR TAMPONADE, BUT THE PERFORATION WAS STILL PRESENT. AT THIS POINT A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR FURTHER TREATMENT, BUT THE DEVICE GOT STUCK IN THE GUIDE CATHETER AND THE STENT STRIPPED OF THE BALLOON. THE GUIDE CATHETER WAS REMOVED AND DISCARDED ALONG WITH BALLOON CATHETER AND PK PAPYRUS STENT STILL IN GUIDE. A NEW GUIDING CATHETER WAS USED, AND ANOTHER PK PAPYRUS WAS SUCCESSFULLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967922 ↗
• MalfunctionNov 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT FELL OFF THE BALLOON PRIOR TO INSERTION. ANOTHER PK PAPYRUS WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804811 ↗
• DeathOct 22, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING THE TREATMENT OF A CALCIFIED PROX. LAD LESION A TYPE III PERFORATION OCCURRED AFTER ROTABLATION; TO STOP THE BLEEDING BALLOON DILATION WAS PERFORMED. IN THE NEXT STEP, THE AFFECTED PK PAPYRUS COVERED STENT SYSTEM (3.0/20) WAS SUCCESSFULLY DELIVERED TO SEAL THE LESION BUT FAILED TO INFLATE IN THE CALCIFIED VESSEL DUE TO PINHOLE RUPTURE OF THE STENT BALLOON. THE AFFECTED PK PAPYRUS SYSTEM WAS REMOVED AND ANOTHER PK PAPYRUS SYSTEM (2.5/20) WAS SUCCESSFULLY IMPLANTED. HOWEVER, THERE WAS NO FLOW TO THE LAD. DESPITE CARDIOPULMONARY RESUSCITATION (CPR), THE PATIENT PASSED AWAY.

  Patient problems: Cardiogenic Shock

  MAUDE report 12685489 ↗
• MalfunctionJan 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE CX. DURING PCI WITH ORBITAL ATHERECTOMY AND STENTING A PERFORATION HAPPENED. WHEN TRYING TO DELIVER THE FIRST PK PAPYRUS, THE STENT BEGAN TO STRIP BUT THEY WERE ABLE TO SUCCESSFULLY DELIVER IT. A 2ND PK PAPYRUS WAS SUCCESSFULLY DELIVERED TO OVERLAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11243330 ↗
• MalfunctionJul 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LCX. RESISTANCE WAS FELT WHILE ATTEMPTING TO INSERT THE DEVICE. DURING WITHDRAWAL IT WAS NOTICED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT DISLODGED INSIDE THE CATHETER. THE STENT WAS RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10334312 ↗
• MalfunctionJun 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS US COVERED STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A VERY CALCIFIED AND TORTUOUS LAD. THE PK PAPYRUS STENT SYSTEM WAS DEFORMED DURING THE ATTEMPT TO CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135683 ↗
• InjuryDec 30, 2019Positioning Problem; Positioning Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION DURING A PROCEDURE WITH A DES. THE PERFORATION COULD NOT BE SEALED PROPERLY. FURTHER INFORMATION WAS REQUESTED BUT UNSUCCESSFUL SO FAR.

  Patient problems: Injury

  MAUDE report 9531413 ↗
• MalfunctionNov 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED TO TREAT A PERFORATION IN THE LAD. AS IT WAS TRIED TO DEPLOY THE STENT IT DISLODGED FROM THE BALLOON. THEREFORE THE DISLODGED STENT WAS RETRIEVED BY USING A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9317590 ↗
• DeathJul 1, 2019Malposition of Device; Malposition of Device

  THE PK PAPYRUS US COVERED STENT SYSTEM WAS SELECTED FOR USE TO TREAT A DISSECTION. THE STENT WAS DELIVERED SUCCESSFULLY, HOWEVER THE PERFORATION PERSISTED. SUBSEQUENT STENTS WERE DELIVERED TO ANOTHER AREA. THE PATIENT REMAINED IN THE HOSPITAL AFTER THIS PROCEDURE, SUFFERED FROM TWO STROKES AND PASSED AWAY 5 DAYS AFTER THE PROCEDURE. THERE WERE MULTIPLE DEVICES USED IN THIS CASE. PLEASE SEE REPORTS: MDR-1028232-2019-02674, MDR-1028232-2019-02675, MDR-1028232-2019-02677, MDR-1028232-2019-02678, MDR-1028232-2019-02679.

  Patient problems: Death; Perforation; Vascular Dissection; Vasoconstriction

  MAUDE report 8750636 ↗