PK Papyrus 2.5/20/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 07640130447219), received between May 8, 2019 and Aug 28, 2026 — classified as 11 deaths, 14 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (73 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 25 most recent of 105 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 8043892-2026-08114.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50492893 ↗
• MalfunctionAug 27, 2026Failure to Advance

  The PK Papyrus covered stent system was selected for treatment of a lesion in the distal RCA. The device was inserted into the patient's body but could not pass the lesion. As a result, the device was removed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50469883 ↗
• DeathAug 24, 2026Lack of Effect

  During balloon dilatation of the prox. LCX, an Ellis Type III coronary peroration occurred. Three PK Papyrus coronary covered stents were implanted in an attempt to control the bleeding. Despite the treatment performed, the perforation was reported as not successfully sealed. The patient died during the procedure due to hemorrhage from coronary perforation. The physician stated that this the bleeding might have resulted from concurrent or late micro perforation of the LAD, a small ramus branch, or the LM. The cause of the reported event is currently under investigation. This report pertains to one of three PK Papyrus devices used in the same procedure involving the same patient and clinical event. The other two devices are reported separately under MDR Report 8043892-2006-073003 and 8043892-2006-073004.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50400887 ↗
• MalfunctionFeb 12, 2026Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN MID LCX. IN ORDER TO STOP BLEEDING, BALLOON DILATATION WAS PERFORMED FIRST. THEN THE PK PAPYRUS WAS INTRODUCED BUT DID NOT CROSS. BLEEDING WAS STOPPED WITH BALLOON DILATATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321677 ↗
• MalfunctionFeb 4, 2026Fracture

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE LAD CAUSED BY THE WIRE. BALLOON DILATATION WAS PERFORMED IN ORDER TO STOP THE BLEEDING. AN ATTEMPT WAS THEN MADE TO USE THE COMPLAINT PK PAPYRUS, BUT IT BROKE PRIOR TO DEPLOYMENT. SUBSEQUENTLY, ANOTHER PK PAPYRUS WAS USED WHICH WAS SUCCESSFULLY IMPLANTED AND SEALED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256047 ↗
• MalfunctionDec 4, 2025Failure to Advance; Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LEFT MAIN. THE DEVICE WOULD NOT CROSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713362 ↗
• MalfunctionSep 26, 2025Failure to Advance; Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III IN THE RCA. THREE DEVICES WERE UNABLE TO ADVANCE. THIS IS TWO OF THREE. TWO OTHER PK PAPYRUS COVERED STENTS WERE IMPLANTED AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23153577 ↗
• MalfunctionAug 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE MID LCX WITH A DES DURING WHICH A CORONARY ARTERY PERFORATION TYPE II OCCURRED. TO STOP THE BLEEDING, PROLONGED BALLOON INFLATION WAS PERFORMED. WHILE ADVANCING THE AFFECTED PK PAPYRUS INTO THE PROXIMAL LCX, THE STENT DISLODGED FROM THE BALLOON. THE DELIVERY SYSTEM WAS WITHDRAWN. AFTER AN UNSUCCESSFUL SNARING ATTEMPT, THE DISLODGED STENT WAS TRAPPED WITH A STENT. POST-DILATION WAS PERFORMED WITH A 3.0 MM NC BALLOON. THE PERFORATION WAS SUCCESSFULLY SEALED BY BALLOON TAMPONADE, FOLLOWED BY STENTING. THE TREATING PHYSICIAN RATED THE OCCURRENCE AS NO PROCEDURE- BUT DEVICE-RELATED COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858471 ↗
• MalfunctionJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION OF THE LCX. FIRST, BALLOON DILATATION WAS PERFORMED TO STOP THE BLEEDING. THEN THE PK PAPYRUS WAS INTRODUCED BUT THE STENT CAME OFF BALLOON INSIDE BODY BEFORE DEPLOYMENT. THE STENT WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE BODY. TWO OTHER PK PAPYRUS STENTS WERE IMPLANTED IN AN OVERLAPPING MANNER AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528724 ↗
• MalfunctionJun 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT CAME OFF IN THE 6F GUIDLINER. THE DEVICE NEVER MADE IT OUTSIDE THE GUIDELINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292881 ↗
• MalfunctionApr 23, 2025Material Deformation; Material Deformation

  TWO PK PAPYRUS COVERED STENT SYSTEMS WERE CHOSEN FOR THE TREATMENT OF A TYPE III PERFORATION IN THE MAIN BRANCH OF THE LCX, BUT BOTH COULD NOT PASS THE LESION AND GOT DAMAGED.. STENT STRUTS WERE STICKING UP. THE PHYSICIAN RATED THIS EVENT AS NEITHER DEVICE NOR PROCEDURE RELATED. THIS IS 1OF 2. THE DEVICE WAS USED AFTER UBD. THE SECOND PK PAPYRUS IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892375 ↗
• MalfunctionFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION IN THE MID LAD. THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND WAS RETRIEVED. IT WAS NOT POSSIBLE TO DELIVER AN ADDITIONAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355524 ↗
• InjurySep 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PK PAPYRUS COVERED STENT WAS ATTEMPTED TO IMPLANT TO COVER A TYPE III CS/IV PERFORATION IN THE LCX (OCCURRED AFTER ROTABLATION) BUT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE BUT FAILED, AND THE STENT STRIPPED OFF THE BALLOON AS IT WAS BEING WITHDRAWN. THE STENT WAS ON THE WIRE COMPLETELY OUTSIDE THE LEFT MAIN CORONARY ARTERY. AT THIS POINT, GIVEN THE ONGOING PERFORATION AND RISK OF PERICARDIAL TAMPONADE, IT WAS DECIDED TO WITHDRAW STENT. SYSTEM WAS REMOVED, BUT IT WAS NOTED THAT THE STENT WAS NOT PRESENT ON THE WIRE INDICATING THE STENT EMBOLIZED BEYOND THE ARCH OF THE AORTA. MULTIPLE ATTEMPTS WERE PERFORMED TO BALLOON TAMPONADE THE PERFUSING MULTIPLE BALLOONS. PATIENT DEVELOPED CHEST PAIN AND ECHOCARDIOGRAM SHOWED A MODERATELY LARGE PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED AND A PERICARDIAL DRAIN WAS PLACED. PATIENT RECEIVED BLOOD TRANSFUSION. PROTAMINE WAS ADMINISTERED. AT THE CONCLUSION OF THE PROCEDURE THERE WAS EVIDENCE THAT THE PERICARDIAL EFFUSION RESOLVED COMPLETELY.

  Patient problems: Chest Pain

  MAUDE report 20241683 ↗
• MalfunctionSep 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION IN THE PROXIMAL TO MID RCA. THE STENT STRIPPED OFF THE DELIVERY BALLOON IN THE PROXIMAL RCA. IT WAS NOT POSSIBLE TO REMOVE THE STENT. THEREFORE, THE STENT WAS DEPLOYED IN PROXIMAL RCA WITH GOOD APPOSITION. AN ADDITIONAL PK PAPYRUS WAS IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20147488 ↗
• MalfunctionJul 3, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  DURING AN EMERGENCY CASE, IT WAS INTENDED TO TREAT A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF A SIDE BRANCH OF THE MEDIAL LCX. THE PATIENT WAS UNDER CONSTANT DEFIBRILLATION, INTUBATED AND SEDATED DURING THE ENTIRE INTERVENTION. DURING LESION PREPARATION AND ACCESS WITH A GUIDE WIRE, A CORONARY ARTERY PERFORATION TYPE III OCCURRED. PERFORATION MECHANISM: GUIDE WIRE. TO STOP THE BLEEDING, SEVERAL BALLOON DILATIONS WITH UP TO 10 MINUTES WERE PERFORMED, AND A PERICARDIAL DRAIN WAS PLACED. THEREAFTER, UNDER USE OF A 7F EBU GUIDING CATHETER AND A 7F INTRODUCER SHEATH, THE PK PAPYRUS 2.5/20 WAS ADVANCED TOWARDS THE TARGET PERFORATION BUT WAS UNABLE TO CROSS THE TARGET AREA. DURING WITHDRAWAL, THE STENT OF THE COMPLAINT DEVICE DISLODGED FROM THE BALLOON (REPORTED SEPARATELY). IT WAS REPORTED THAT BOTH, THE DELIVERY SYSTEM AND THE DISLODGED STENT, WERE SAFELY REMOVED FROM THE PATIENT. AS THE BLEEDING PERSISTS, THE COMPLAINT PK PAPYRUS 2.5/20 OF THE SAME LOT WAS SELECTED AND WAS ADVANCED TOWARDS THE TARGET PERFORATION BUT WAS UNABLE TO CROSS THE TARGET AREA AND HAD TO BE REMOVED. AFTER WITHDRAWAL, IT WAS NOTICED THAT THE STENT BECAME DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669137 ↗
• MalfunctionJul 3, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  DURING AN EMERGENCY CASE, IT WAS INTENDED TO TREAT A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF A SIDE BRANCH OF THE MEDIAL LCX. THE PATIENT WAS UNDER CONSTANT DEFIBRILLATION, INTUBATED AND SEDATED DURING THE ENTIRE INTERVENTION. DURING LESION PREPARATION AND ACCESS WITH A GUIDE WIRE A CORONARY ARTERY PERFORATION TYPE III OCCURRED. PERFORATION MECHANISM: GUIDE WIRE. TO STOP THE BLEEDING, SEVERAL BALLOON DILATIONS WITH UP TO 10 MINUTES WERE PERFORMED, AND A PERICARDIAL DRAIN WAS PLACED. THEREAFTER, UNDER USE OF A 7F EBU GUIDING CATHETER AND A 7F INTRODUCER SHEATH, THE COMPLAINT PK PAPYRUS 2.5/20 WAS ADVANCED TOWARDS THE TARGET PERFORATION BUT WAS UNABLE TO CROSS THE TARGET AREA. DURING WITHDRAWAL, THE STENT OF THE COMPLAINT DEVICE DISLODGED FROM THE BALLOON. IT WAS REPORTED THAT BOTH, THE DELIVERY SYSTEM AND THE DISLODGED STENT WERE SAFELY REMOVED FROM THE PATIENT. AS THE BLEEDING PERSISTS, A SECOND PK PAPYRUS 2.5/20 OF THE SAME LOT WAS SELECTED (REPORTED SEPARATELY) AND WAS ADVANCED TOWARDS THE TARGET PERFORATION BUT WAS UNABLE TO CROSS THE TARGET AREA AND HAD TO BE REMOVED. AFTER WITHDRAWAL, IT WAS NOTICED THAT THE STENT BECAME DEFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668703 ↗
• InjuryMay 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING TREATMENT OF A LM TO LAD LESION WITH SEVERAL DES, A TYPE III CS/IV PERFORATION OCCURRED. THE AFFECTED PK PAPYRUS 2.5/20 COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT AND IMPLANTED IN MID LAD WHICH COVERED THE PERFORATION BUT CAUSED A NEW PERFORATION AT THE DISTAL EDGE OF THE STENT. A PK PAPYRUS 2.5/15 WAS INTRODUCED BUT THE STENT GOT CAUGHT ON A LEFT MAIN STENT AND STRIPPED OFF THE BALLOON (REPORTED SEPARATELY). IMPLANTATION OF AN ADDITIONAL PK PAPYRUS 2.5/15 SUCCESSFULLY SEALED THE NEW PERFORATION.

  Patient problems: Perforation of Vessels

  MAUDE report 19331558 ↗
• MalfunctionMay 14, 2024Material Deformation; Material Deformation

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE LCX. WHEN DEVICE WAS REMOVED FROM HOOP, THE TECH NOTICED THE PROXIMAL EDGE OF PK PAPYRUS WAS DAMAGED. DEVICE WAS SET ASIDE AND NOT USED, AND ANOTHER PK PAPYRUS WAS OPENED AND USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310698 ↗
• MalfunctionApr 15, 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 MID RCA. THE PK PAPYRUS DISLODGED FROM THE BALLOON INTO PATIENT NATIVE MRCA. THE PERFORATION WAS SEALED WITH THE IDENTIFIED DISLODGED PK PAPYRUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104830 ↗
• MalfunctionFeb 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE DISTAL LCX. THE STENT EMBOLIZED IN THE PATIENT. PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799480 ↗
• MalfunctionFeb 14, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE SVG-D1 BRANCH. THE DEVICE WAS ADVANCED THROUGH A 7 F GUIDE WITH A 6 F GUIDELINER GUIDE EXTENSION. PK PAPYRUS WOULD NOT CROSS THE LESION AND WAS REMOVED. IT WAS STATED THAT THE STENT SEEMED TO BE ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED. WHEN THE PK PAPYRUS WAS BEING LOADED ON THE WIRE IT WAS NOTICED THAT THE STENT WAS MISSING. THE FIELD, SCRUB TABLE, FLOOR AND SURROUNDING AREAS WERE CHECKED THOROUGHLY, BUT THE UNDEPLOYED STENT WAS NOT LOCATED. AN ADDITIONAL PK PAPYRUS WITH SAME SIZE WAS DEPLOYED AND THE PATIENT WAS STABLE WHEN LEAVING THE CATH LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18706761 ↗
• MalfunctionJan 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD, BUT THE STENT STRIPPED OFF BALLOON AND WAS DEPLOYED IN THE PROXIMAL LAD, NOT AT SITE OF PERFORATION. A SECOND PK PAPYRUS WAS DEPLOYED AND SUCCESSFULLY SEALED THE PERFORATION. IT WAS STATED BY THE PHYSICIAN THAT THE EVENT IS NOT A DEVICE-RELATED COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18514977 ↗
• MalfunctionDec 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE PROXIMAL RCA. SINCE THE STENT FELL OFF OF THE BALLOON CATHETER OUTSIDE PATIENT, IT WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311543 ↗
• DeathOct 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. THE DEVICE WAS INSERTED BUT WAS REMOVED TO INSERT A GUIDELINER. THE STENT CAME OFF DURING REMOVAL. PATIENT PASSED AWAY TWO DAYS LATER DUE TO CARDIOGENIC SHOCK. THE PHYSICIAN RATED THE DEATH AS NOT DEVICE RELATED.

  Patient problems: Cardiogenic Shock

  MAUDE report 17916434 ↗
• DeathSep 13, 2023Failure to Advance; Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE LM. THE COMPLAINT PK PAPYRUS 2.5/20 DID NOT CROSS AND WAS WITHDRAWN. THE VESSEL WAS DILATED MORE, AND A PK PAPYRUS 4.0/20 WAS IMPLANTED. THE PERFORATION DID NOT SEAL (REPORTED SEPARATELY), AND THE PATIENT EXPIRED DUE TO CORONARY PERFORATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 17742098 ↗