PK Papyrus 3.5/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07640130447172), received between Jun 26, 2019 and Aug 31, 2026 — classified as 7 deaths, 7 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Material Deformation

  The PK Papyrus covered stent system was selected for treatment of an injury occurred during a surgical procedure of the right ICA. The stent was damaged when introduced into hemostasis valve. Another PK Papyrus was successfully used.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515350 ↗
• DeathMar 13, 2026Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION IN THE LAD. WHILE DELIVERING THE STENT, IT BECAME DISLODGED FROM BALLOON CATHETER AND EMBOLIZED IN THE CORONARY ARTERY. ON THE SAME DAY, THE PATIENT PASSED AWAY DUE TO CARDIOGENIC SHOCK AND ARREST.

  Patient problems: Cardiac Arrest; Cardiogenic Shock

  MAUDE report 24589698 ↗
• MalfunctionFeb 13, 2026Device Dislodged or Dislocated

  FOUR PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A PERFORATION IN AN SVG. ONE STENT (COMPLAINT DEVICE) DISLODGED FROM BALLOON. THE PERFORATION WAS SEALED WITH THE OTHER THREE PK PAPYRUS STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330607 ↗
• MalfunctionApr 3, 2025Failure 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 III PERFORATION. THE DEVICE WAS ADVANCED BUT WOULD NOT CROSS THE ANGULATED SEGMENT IN PROXIMAL-MID LAD. DEVICE WAS REMOVED. GUIDE LINER TAKEN INTO THE LAD OVER A BALLOON. USING THE GUIDELINER ATTEMPTED TO DELIVER THE PAPYRUS AGAIN AND ABLE TO DELIVER IT ACROSS THE BEND IN THE MORE PROXIMAL SEGMENT OF THE LAD. STENT TAKEN TO THE MID LAD AT THE SITE OF THE PERFORATION. STENT MOVED BACK AND FORTH TO TRY TO POSITION IT PERFECTLY AND AT THIS TIME IT APPEARED THAT THE STENT STRIPPED OFF THE BALLOON. IT WAS POSSIBLE TO INFLATE A 3.0 BALLOON TO DEPLOY THE STENT. THE TREATING PHYSICIAN RATED THE OCCURRENCE AS NON-DEVICE-RELATED AND NON-PROCEDURE-RELATED COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764339 ↗
• DeathDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF TYPE IIICS/IV PERFORATION IN THE PROXIMAL LAD. TO STOP THE BLEEDING, BALLOON DILATION WAS PERFORMED. THEREAFTER, THE AFFECTED PK PAPYRUS WAS INTRODUCED INTO THE PATIENTS BODY, BUT THE STENT DISLODGED FROM THE BALLOON PRIOR TO DEPLOYMENT. A SECOND PK PAPYRUS WAS IMPLANTED TO COVER THE UNDEPLOYED STENT. THE PERFORATION WAS SUCCESSFULLY SEALED. HOWEVER, THE PATIENT SUFFERED FROM PERICARDIAL TAMPONADE DUE TO WHICH A PERICARDIAL DRAIN WAS INSERTED. ALSO, RESUSCITATION WAS PERFORMED. 5 DAYS LATER THE PATIENT PASSED AWAY DUE TO MULTI SYSTEM ORGAN FAILURE. IT WAS STATED THAT THE DEATH WAS NOT ATTRIBUTED TO THE PK PAPYRUS.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 20827586 ↗
• InjuryNov 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PK PAPYRUS COVERED STENTS WERE SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE PROXIMAL TO MID PART OF THE LAD. AFTER THE PLACEMENT OF THE SECOND PAPYRUS STENT THERE WAS ANOTHER PERFORATION AT THE STENT EDGE THAT WAS CAUSED BY THE PLACEMENT (POST-DILATATION). AN ADDITIONAL PK PAPYRUS STENT WAS IMPLANTED IN AN OVERLAPPING MANNER AND THE PERFORATION WAS SEALED.

  Patient problems: Perforation of Vessels

  MAUDE report 20711171 ↗
• DeathSep 9, 2024Use of Device Problem; Use of Device Problem

  A TYPE III PERFORATION IN THE MID LAD HAD OCCURRED. BALLOON DILATATION WAS PERFORMED IN ORDER TO STOP THE BLEEDING BUT WAS NOT SUCCESSFUL. SUBSEQUENTLY, THREE PK PAPYRUS COVERED STENTS WERE IMPLANTED ON (B)(6) 2024 AND THE PERFORATION WAS SUCCESSFULLY SEALED. ONE OF THE COVERED STENTS (3.5/15) WAS EXPIRED ON (B)(6) 2024. THE FOLLOWING DAY, THE PATIENT DIED DUE TO CARDIO-PULMONARY ARREST. THE TREATING PHYSICIAN RATED THE OCCURRENCE AS A NEITHER DEVICE-RELATED NOR PROCEDURE-RELATED COMPLICATION.

  Patient problems: Cardiac Arrest

  MAUDE report 20170542 ↗
• MalfunctionAug 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A 3.5/15 PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID RCA. THE STENT STRIPPED OFF THE DELIVERY SYSTEM (COMPLAINT DEVICE). IT WAS RETRIEVED AND ANOTHER 4.0/15 PK PAPYRUS WAS ATTEMPTED TO BE PLACED, BUT AGAIN THE STENT STRIPPED OFF THE DELIVERY SYSTEM (REPORTED SEPARATELY). IT WAS RETRIEVED. ANOTHER 4.0/20 PK PAPYRUS WAS IMPLANTED SUCCESSFULLY AND SEALED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907452 ↗
• MalfunctionApr 5, 2024Device Slipped; Failure to Advance; Device Dislodged or Dislocated; Device Slipped; Failure to Advance; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION IN A SEVERELY CALCIFIED PROXIMAL OM LESION. A COMPLEX HIGH RISK PCI WAS PERFORMED AND POST STENT ANGIOGRAPHY DEMONSTRATED A PROXIMAL LCX AND PROXIMAL OM1 INTRAMURAL HEMATOMA AND PERFORATION IN THE PROXIMAL LCX. A 3.5/15 PK PAPYRUS COVERED STENT WAS INSERTED, BUT THE STENT DISLODGED FROM ITS ORIGINAL POSITION ON THE DELIVERY BALLOON WHEN IT WAS UNABLE TO CROSS LESION. IT WAS REMOVED FROM THE PATIENT AND A NEW 2.5/15 PK PAPYRUS COVERED STENT WAS DEPLOYED TO THE PROXIMAL OM1 PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051362 ↗
• MalfunctionNov 7, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. IT WAS NOT POSSIBLE TO DELIVER STENT AND IT WAS REMOVED. UPON REMOVAL, STRUT LOOKED BENT SO GUIDE EXTENSION WAS USED. NEW PK PAPYRUS WAS INSERTED AND SUCCESSFULLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085998 ↗
• MalfunctionSep 13, 2023Lack of Effect; Lack of Effect

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION IN THE MID LAD. THIS IS THE SECOND OF THREE PK PAPYRUS COVERED STENTS THAT FAILED TO SEAL IN THE MID LAD. EACH IS REPORTED SEPARATELY.

  Patient problems: Insufficient Information

  MAUDE report 17735797 ↗
• 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. A PK PAPYRUS 4.5/15 WAS INTRODUCED INTO THE PATIENTS BODY, BUT THE STENT DISLODGED FROM THE BALLOON (REPORTED SEPARATELY). THE STENT WAS SNARED SUCCESSFULLY. ALSO, THE COMPLAINT PK PAPYRUS US 3.5/15 WAS INTRODUCED INTO THE PATIENTS BODY BUT AGAIN THE STENT DISLODGED FROM THE BALLOON. 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 SHOC

  Patient problems: Cardiogenic Shock

  MAUDE report 17416532 ↗
• MalfunctionJul 14, 2023Lack of Effect; Lack of Effect

  PK PAPYRUS COVERED STENT SYSTEMS (PKP) WERE SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE MID LAD. THE FIRST PKP WAS ATTEMPTED TO BE INTRODUCED WITH THE HELP OF A GUIDELINER DEVICE. SEVERAL ATTEMPTS WERE UNSUCCESSFUL. THE PKP WAS PULLED BACK IN GUIDELINER AND RESISTANCE WAS FELT, SO EVERYTHING WAS TAKEN OUT TOGETHER. WHEN ALL WAS BACK ON THE TABLE, IT WAS ATTEMPTED TO USE A NEW GUIDELINER BUT THE SAME PKP. DURING REMOVAL OF THE PKP FROM GUIDELINER BACK ON TABLE, THE PKP DELIVERY SYSTEM CAME OUT, BUT THE STENT STAYED INSIDE THE GUIDELINER. A NEW GUIDELINER WAS USED, AND IT WAS PROCEEDED TO BALLOONING THE PERFORATION SITE SEVERAL TIMES. THEN A NEW PKP (2ND) WAS USED AND WAS SUCCESSFULLY DELIVERED, BUT FURTHER BLEEDING WAS DETECTED. A 3RD PK PAPYRUS WAS INTRODUCED BUT COULD NOT CROSS AND WAS THEREFORE WITHDRAWN. THE BLEEDING WAS THEN TREATED WITH PROLONGED BALLOON INFLATION. AT THAT TIME THE BLEEDING STOPPED, AND THE PERFORATION WAS SUCCESSFULLY SEALED. PATIENT IS FINE AND HAS RECOVERED. THIS REFERS TO THE 2ND PK PAPYRUS. THE OTHER TWO PKPS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325557 ↗
• MalfunctionMay 15, 2023Lack of Effect; Lack of Effect

  FOUR PK PAPYRUS COVERED STENT SYSTEM WERE USED FOR TREATMENT OF THE LAD. THE 1ST THREE STENTS DISLODGED PRIOR TO INTRODUCTION INTO PATIENTS BODY, AND THE 4TH STENT DISLODGED INSIDE THE BODY. THIS 4TH STENT WAS RETRIEVED. ALL FOUR PK PAPYRUS STENTS ARE REPORTED SEPARATELY. IT WAS REPORTED THAT THE PERFORATION COULD BE SEALED. HOWEVER, THE PATIENT REMAINS HOSPITALIZED. THE REASON FOR THE PROLONGATION IS UNCLEAR. FURTHER INFORMATION IS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16934968 ↗
• MalfunctionMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THREE PK PAPYRUS COVERED STENTS WERE USED FOR TREATMENT OF A TYPE III PERFORATION IN THE LCX. STENTS #1 AND #2 PARTIALLY STRIPPED OFF OF BALLOON BUT WERE ABLE TO BE REMOVED. STENT #3 STRIPPED OFF OF THE BALLOON IN THE CORONARY ARTERY. IT WAS ULTIMATELY RETRIEVED VIA SNARE AND REMOVED, INTACT, FROM THE BODY. THE PERFORATION SEALED SPONTANEOUSLY WITH BALLOON TAMPONADE ALONE. IT IS UNSURE WHICH LOT NUMBERS RELATES TO WHICH STENT. THE OTHER STENTS WERE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906621 ↗
• InjuryMay 1, 2023Fracture; Fracture

  DURING TREATMENT OF A PERFORATION IN THE LAD, THE PK PAPYRUS COVERED STENT SYSTEM BROKE IN TWO PARTS AND ONE PORTION OF THE STENT REMAINED INSIDE THE PATIENT. PATIENT WAS TRANSFERRED TO MEDICAID MANAGED CARE (MMC) FOR A CORONARY ARTERY BYPASS GRAFTING (CABG).

  Patient problems: Insufficient Information

  MAUDE report 16848157 ↗
• MalfunctionMar 30, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE DISTAL RCA. THE INITIAL ATTEMPT TO SEAL THE LEAKAGE WAS UNSUCCESSFUL. TWO OTHER PKPS WERE USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645745 ↗
• InjuryMar 21, 2023Lack of Effect; Lack of Effect

  DURING PCI OF THE MID LAD LESION WITH A DES, A TYPE III PERFORATION WAS DETECTED. PROLONGED BALLOON TAMPONADE WAS PERFORMED WITHOUT SEALING THE PERFORATION. SUBSEQUENTLY, PROCEEDED WITH THE PK PAPYRUS COVERED STENT WITH CONTAINMENT OF PERFORATION. PATIENT WAS TRANSFERRED TO FLOOR. HOWEVER, WHILE THERE, PATIENT BECAME HYPOTENSIVE REQUIRING EMERGENT ECHOCARDIOGRAM THAT SHOWED PERICARDIAL TAMPONADE. TAKEN BACK TO THE CATH LAB, UNDERWENT REPEAT CARDIAC CATHETERIZATION WITH PLACEMENT OF ANOTHER PAPYRUS COVERED STENT DUE TO RESIDUAL PERFORATION WITH SUCCESS. PATIENT WAS DISCHARGED HOME ON (B)(6) 2023.

  Patient problems: Cardiac Tamponade

  MAUDE report 16588368 ↗
• MalfunctionFeb 15, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. THE PRE-DILATED LESION COULD NOT BE CROSSED WITH THE PK PAPYRUS. UPON PULLING THE DEVICE BACK INTO THE 6F GUIDELINER, THE STENT CAME OFF THE DELIVERY SYSTEM IN THE PROX LAD. THE STENT WAS ADAPTED TO THE VESSEL WALL. ANOTHER PK PAPYRUS WAS USED FOR THE TARGET AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16378270 ↗
• MalfunctionFeb 14, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE PROXIMAL LAD. THE COVERED STENT WAS PLACED OVER PERFORATION AND DID NOT SEAL THE PERFORATION COMPLETELY. A SECOND PK PAPYRUS WAS PULLED AND DEPLOYED IN THE SAME AREA TO ACHIEVE COMPLETE SEALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375664 ↗
• DeathFeb 13, 2023Lack of Effect; Lack of Effect

  DURING STENTING OF A SEVERELY CALCIFIED LESION WITH 99 PERCENT STENOSIS DEGREE IN THE MID RCA, A TYPE III PERFORATION OCCURRED IN THE PROXIMAL RCA. AN EMERGENT BYPASS AND LIGATION OF THE PERFORATION WAS DISCUSSED, BUT FIRST CONTROLLING OF THE PERFORATION WITH OTHER METHODS WAS PREFERRED. SUBSEQUENTLY, PK PAPYRUS COVERED STENTS WERE USED TO SEAL THE PERFORATION. THE SEALING COULD BE ACHIEVED WITH IMPLANTING THE THIRD STENT. AFTERWARDS, THE SEVERE STENOSIS DISTALLY WAS TREATED WITH TWO DRUG-ELUTING COMPETITORS STENTS. THE VESSEL WAS FULLY REVASCULARIZED, NO SIGNIFICANT STENOSIS, NO EDGE DISSECTION AND NOT FURTHER EXTRAVASATION OF CONTRAST. AN IMPELLA WAS PLACED DURING THE PROCEDURE. FOLLOWING THE INTERVENTION, THE PATIENT WENT TO BYPASS SURGERY. 16 DAYS AFTER SURGERY PATIENT DIED DUE TO CARDIOGENIC SHOCK. THIS COMPLAINT REFERS TO THE SECOND STENT. THE OTHER TWO STENTS ARE REPORTED SEPARATELY.

  Patient problems: Cardiogenic Shock

  MAUDE report 16363215 ↗
• MalfunctionFeb 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. WHEN OPENING THE BOX IT WAS DISCOVERED THAT THE STENT WAS DEFECTIVE. SPECIFICALLY, IT APPEARS THAT THERE IS STRINGY MATERIAL PEELING OFF OF THE COVER. THE STENT NEVER REACHED THE PATIENT AS THE TECH NOTICED IT RIGHT AWAY. ANOTHER PK PAPYRUS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16305017 ↗
• MalfunctionNov 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SPLENIC ARTERY ANEURYSM. IT WAS PLANNED TO PLACE THE STENT IN THE SPLENIC ARTERY BUT CAME OFF DELIVERY SYSTEM WHILE BEING RETRACTED FROM PATIENT UNDEPLOYED. THE STENT THEN WAS SEATED IN THE GDA, WHERE THEY HAD EMBOLIZED COILS DUE TO BLEEDING. ATTEMPTS WERE MADE TO RETRIEVE THE STENT, BUT THEY WERE UNSUCCESSFUL. IT WAS DECIDED TO LEAVE IT IN THE PROXIMAL GDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880640 ↗
• MalfunctionOct 12, 2022Lack of Effect

  DURING TREATMENT OF A TOTAL OCCLUSION IN THE PROXIMAL LAD WITH A DES, A TYPE III PERFORATION (2MM LENGTH) HAD OCCURRED. FOUR PK PAPYRUS COVERED STENTS WERE SELECTED FOR TREATMENT OF THE PERFORATION, BUT THEY DID NOT COMPLETELY SEAL THE PERFORATION. CONTRAST EXTRAVASATION PERSISTED. HOWEVER, IT WAS SIGNIFICANTLY IMPROVED. FURTHER BALLOON DILATATION WAS DONE, AND MEDICATION WAS GIVEN TO STOP THE BLEEDING. THE PATIENT COULD BE DISCHARGED HOME. THIS IS ONE OF FOUR. DEVICE CODE IS 4065.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587260 ↗
• MalfunctionSep 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS ATTEMPTED TO PUT MULTIPLE PK PAPYRUS STENTS THROUGH A GUIDE LINER THAT WAS NOT LARGE ENOUGH TO ACCOMMODATE THE STENTS. THREE 3.5/15 PK PAPYRUS CAME OFF, TWO IN THE GUIDE AND ONE IN THE SHEATH. THEY WERE ALL REMOVED WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15385235 ↗