PK Papyrus 4.0/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640130447189), received between Sep 30, 2019 and Aug 21, 2025 — classified as 2 deaths, 11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Failure 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 LESION IN THE DISTAL RCA WITH DES DURING WHICH A CORONARY ARTERY PERFORATION TYPE II OCCURRED (PERFORATION LENGTH 20 MM, REFERENCE VESSEL DIAMETER 4.0 MM). TO STOP THE BLEEDING, PROLONGED BALLOON INFLATION WAS PERFORMED, BUT STILL A PERSISTENT BLEEDING WAS DETECTED. THE AFFECTED PK PAPYRUS WAS INTRODUCED INTO THE PATIENT'S BODY BUT "THE STENT WAS CAUGHT ON THE PROXIMAL STENT AND DISLODGED FROM THE BALLOON INTO THE DISTAL RCA". THE DELIVERY SYSTEM WAS WITHDRAWN. AFTER AN UNSUCCESSFUL SNARING ATTEMPT, THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL WITH A NC BALLOON AND EVENTUALLY OVER-STENTED WITH A PK PAPYRUS 4.0/20 WHICH SEALED THE PERFORATION SUCCESSFULLY. THE TREATING PHYSICIAN RATED THE OCCURRENCE AS DEVICE-RELATED COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22859233 ↗
• MalfunctionDec 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION WHICH PROGRESSED TO TYPE III IN THE PROXIMAL LCX. THE PERFORATION OCCURRED DURING IMPLANTATION OF A DES. AFTER INTRODUCTION OF THE PK PAPYRUS, THE STENT DISLODGED FROM THE BALLOON DUE TO THE CALCIFIED LESION. ANOTHER PK PAPYRUS WAS USED AND THE PERFORATION WAS SUCCESSFULLY SEALED. THE EVENT WAS RATED BY THE PHYSICIAN AS NOT DEVICE OR PROCEDURE RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20939335 ↗
• 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 (REPORTED SEPARATELY). IT WAS RETRIEVED AND ANOTHER 4.0/15 PK PAPYRUS WAS ATTEMPTED TO BE PLACED, BUT AGAIN THE STENT STRIPPED OFF THE DELIVERY SYSTEM (COMPLAINT DEVICE). 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 19907447 ↗
• MalfunctionJun 5, 2024Material Deformation; Material Deformation

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD (LESION 90 PERCENT STENOSIS DEGREE). THE STENT WAS ATTEMPTED TO BE PLACED BUT WAS REMOVED UNDEPLOYED AS IT WAS DEFECTIVE. ANOTHER COVERED STENT SYSTEM (SAME LOT) WAS IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473347 ↗
• DeathDec 12, 2023Patient Device Interaction Problem; Lack of Effect; Patient Device Interaction Problem; Lack of Effect

  THE PHYSICIAN INTENDED TO TREAT A LESION IN THE PROXIMAL LAD WITH A DES AND A POST-DILATION BALLOON DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. TO STOP THE BLEEDING, BOTH BALLOON DILATION AND PROTAMINE INJECTION WERE PERFORMED. THEREAFTER, THE AFFECTED PK PAPYRUS 4.0/15 WAS IMPLANTED BUT THE SEALING WAS INCOMPLETE REQUIRING AN ADDITIONAL COVERED STENT. THEREFORE, A PK PAPYRUS US 3.5/15 WAS IMPLANTED AND SEALED THE PERFORATION SUCCESSFULLY. THE PATIENT WAS TRANSFERRED TO ICU. SEVERAL HOURS LATER, A PERICARDIAL HEMATOMA OCCURRED CAUSING PERICARDIAL TAMPONADE REQUIRING SURGICAL EVACUATION. THE PATIENT UNDERWENT RESUSCITATION BUT EVENTUALLY PASSED AWAY. AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, IT WAS CLARIFIED THAT THE PATIENT RECEIVED A TEMPORARY PACEMAKER PLACEMENT OVERNIGHT DUE TO ALTERNATING CONDUCTION ABNORMALITIES WITH PREDOMINANTLY JUNCTIONAL RHYTHM. THE ECGS WERE REVIEWED WITH EVIDENCE OF ALTERNATING CONDUCTION ABNORMALITIES, POSSIBLE JUNCTIONAL BIGEMINY, SINUS TACHYCARDIA WITH 2:1 BLOCK AND JUNCTIONAL ESCAPE, AND JUNCTIONAL RHYTHMS HR IN THE 70S-80S. IN ADDITION, THE PATIENT WAS ON MULTIPLE PRESSORS AND MAPS CONTINUED TO BE BORDERLINE. THE CASE W

  Patient problems: Cardiac Tamponade; Hematoma

  MAUDE report 18311542 ↗
• 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 FIRST OF THREE PK PAPYRUS COVERED STENTS THAT FAILED TO SEAL. EACH IS REPORTED SEPARATELY.

  Patient problems: Insufficient Information

  MAUDE report 17735897 ↗
• 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. A PK PAPYRUS US 3.0/20 WAS INTRODUCED INTO THE PATIENTS BODY AND INFLATED WITH 8 ATM. HOWEVER, THE PERFORATION WAS NOT SEALED SUCCESSFULLY (REPORTED SEPARATELY). THEREFORE, BOTH A DRUG ELUTING STENT AND THE COMPLAINT PK PAPYRUS US 4.0/15 WERE IMPLANTED, BUT STILL THE PERFORATION COULD NOT BE SEALED, DESPITE POST-DILATION WITH TWO BALLOONS. THEREAFTER, THE PATIENT UNDERWENT AN EMERGENT CABG AND PASSED AWAY DUE TO HEMORRHAGIC SHOCK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 17638691 ↗
• MalfunctionMay 17, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. THE STENT DID NOT SEAL COMPLETELY, THEREFORE A SECOND PK PAPYRUS STENT WAS IMPLANTED IN OVERLAPPING MANNER, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946411 ↗
• MalfunctionFeb 28, 2023Inflation Problem; Inflation Problem

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION IN THE POSTERIOR TIBIAL ARTERY. THE DEVICE WAS DELIVERED BUT FAILED TO INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451916 ↗
• MalfunctionFeb 14, 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 LAD. WHEN REMOVING THE STENT CATHETER FROM THE PROTECTIVE HOOP THE STENT WAS PULLED OFF THE CATHETER. THE DEVICE WAS NOT USED, A NEW DEVICE WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375661 ↗
• 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 THREE OF FOUR. DEVICE CODE IS 4065.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587278 ↗
• MalfunctionApr 26, 2022Material Deformation; Material Deformation

  THE PK PAPYRUS WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE LAD. AFTER IMPLANTATION OF A FIRST STENT, THE COMPLAINT INSTRUMENT WAS INTRODUCED INTO THE PATIENTS BODY, BUT THE STENT SYSTEM COULD NOT CROSS THE TARGET LESION AND WAS WITHDRAWN. AFTER WITHDRAWAL, A STENT DEFORMATION WAS DETECTED AT THE TIP. ANOTHER PK PAPYRUS WAS USED TO SUCCESSFULLY SEAL THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207943 ↗
• MalfunctionSep 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS 4.0/15 WAS SELECTED FOR THE TREATMENT OF A PERFORATION IN THE LAD. AS IT WAS NOT POSSIBLE TO PLACE THE PK PAPYRUS PROXIMAL TO PREVIOUSLY IMPLANTED STENTS IT WAS DECIDED TO REMOVE THE PK PAPYRUS. DURING WITHDRAWAL THE STENT DISLODGED FROM THE BALLOON INSIDE THE TELEFLEX GUIDELINER EXTENSION CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135901 ↗