PK Papyrus 4.0/20/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07640130447240), received between Aug 22, 2019 and Sep 21, 2023 — classified as 5 deaths, 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN ELLIS TYPE III CORONARY PERFORATION IN THE PROXIMAL LCX. AFTER BALLOON DILATATION IN ORDER TO STOP THE BLEEDING, THE PK PAPYRUS WAS ADVANCED BUT THE STENT STRIPPED OFF THE BALLOON INSIDE THE LESION. THE DISLODGED STENT WAS REMOVED INTACT, AND ANOTHER PKP WAS USED TO SEAL THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789913 ↗
• DeathSep 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION IN THE MID LAD, OCCURRED DURING POST-DILATATION OF A DES. AFTER IMPLANTATION OF THE COVERED STENT THE VESSEL WAS OCCLUDED, AND THERE WAS AN ACUTE STENT THROMBOSIS. PATIENT EXPIRED DUE TO CARDIOGENIC SHOCK.

  Patient problems: Cardiogenic Shock

  MAUDE report 17778023 ↗
• DeathSep 13, 2023Lack of Effect; Lack of Effect

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 THE PK PAPYRUS 2.5/20 DID NOT CROSS AND WAS WITHDRAWN (REPORTED SEPARATELY).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

  Patient problems: Cardiac Tamponade

  MAUDE report 17742099 ↗
• MalfunctionAug 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN A SAPHENOUS VEIN GRAFT. THE COMPLAINED DEVICE WAS NOT IMPLANTED. IT CAME OFF THE BALLOON AND WAS REMOVED WITH ANOTHER BALLOON. TWO OTHER PK PAPYRUS WERE IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541776 ↗
• MalfunctionJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A TYPE III PERFORATION IN THE MID RCA OCCURRED ON POST-DILATATION OF JUST PLACED STENTS, AND THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS NOT POSSIBLE TO ADVANCE THE PK PAPYRUS STENT TO THE TARGET LESION, AND, UPON REMOVING, THE STENT BECAME DISLODGED FROM THE BALLOON. THERE WAS NO REFLOW. ANOTHER STENT WAS ADVANCED ALONG SIDE THE DISLODGED STENT AND DEPLOYED TO ADAPT THE DISLODGED STENT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075205 ↗
• MalfunctionMay 17, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV IN THE RCA. THE STENT COULD NOT SEAL THE PERFORATION. 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 16946408 ↗
• DeathOct 3, 2022Adverse Event Without Identified Device or Use Problem

  ONE MONTH BEFORE THE COMPLAINT EVENT ON (B)(6) 2022, THE PATIENT WAS SUCCESSFULLY TREATED BY STENTING IN THE MEDIAL LCX. AT THE EVENT DATE, DUE TO CHEST PAIN, THE PATIENT UNDERWENT A DIAGNOSTIC ANGIOGRAPHY TO PREPARE AN RCA STENTING. DURING THE DIAGNOSTIC ANGIOGRAPHY A TYPE III CS/IV PERFORATION IN THE LM OCCURRED WITH A LARGE PERICARDIAL EFFUSION AND THE PATIENT BECAME UNSTABLE. A PERICARDIAL DRAIN WAS PLACED, AND A SIGNIFICANT AMOUNT OF BLOOD WAS EVACUATED FROM THE PERICARDIAL SPACE. AN EMERGENCY STERNOTOMY WAS PERFORMED. THE ALLEGED PERFORATION WAS IDENTIFIED IN THE OSTIAL TO PROXIMAL LAD. TO STOP THE BLEEDING A VEIN GRAFT WAS IMPLANTED TO GRAFT THE LAD. AFTER ADDITIONAL ANGIOGRAPHIES, IT WAS NOTED THAT THE ACTUAL PERFORATION IS NOT IN THE LAD BUT IN THE LM. THE COMPLAINT STENT WAS CHOSEN AND IMPLANTED ACROSS THE PERFORATION IN THE LM AND POST DILATED, BUT THE BLEEDING SITUATION COULD NOT BE STOPPED. THE SITUATION HAS WORSENED MORE, AS THE TEAR WAS NOW NEAR THE LM OSTIUM AND IT WAS PLANNED TO REPLACE THE AORTIC ROOT. DURING THE PREPARATION FOR THAT, A SIGNIFICANT VENOUS BLEEDING IN THE ABDOMEN WAS NOTICED. THE SITUATION WAS AGREED NOT TO BE A SALVAGEABLE SITUATION AND AFTER DISC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15529794 ↗
• DeathSep 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING TREATMENT OF A TYPE III PERFORATION IN THE PROXIMAL RCA, THE PK PAPYRUS WAS INSERTED BUT NO STENT WAS SEEN ON FLUOROSCOPY. ANOTHER PK PAPYRUS STENT WAS IMPLANTED AND SEALED THE PERFORATION SUCCESSFULLY. PATIENT WAS DISCHARGED FROM CATH LAB TO CCU. POST PROCEDURE THE PATIENT DECEASED ON THE SAME DAY.

  Patient problems: Failure of Implant

  MAUDE report 15385245 ↗
• MalfunctionJul 14, 2022Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE RCA, OCCURRED IN CONTEXT OF A POST-DILATATION. ADVANCING THE PK PAPYRUS STENT SYSTEM INTO THE MID RCA STENTED SEGMENT WAS CHALLENGING AND RESULTED IN DISLODGEMENT OF THE STENT. ATTEMPTS TO CAPTURE THE STENT WERE UNSUCCESSFUL. FINALLY, THE STENT WAS DILATED AND TRAPPED AGAINST THE ENDOTHELIUM. ST ELEVATION AND CLOSURE OF PERFORATION WITH PROCEDURE PROLONGATION WAS REPORTED. ACUTE STENT THROMBOSIS, CONFIRMED ON IMAGINING, RELATED TO PK PAPYRUS. FINAL ANGIOGRAPHY REVEALED EXCELLENT TIMI-3 FLOW AND NO EVIDENCE OF PERFORATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15013418 ↗
• InjuryApr 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING BALLOONING THE LAD A PERFORATION HAD OCCURRED. AN EMERGENCY PERICARDIOCENTESIS WAS PERFORMED AND THE PK PAPYRUS WAS SUCCESSFULLY IMPLANTED. THE PERFORATION WAS SEALED. TWO HOURS LATER THE PATIENT EXPERIENCED AN ACUTE STENT THROMBOSIS LEADING TO HEMODYNAMIC INSTABILITY. THE CLOT WAS REMOVED WITH A PENUMBRA ASPIRATION DEVICE AND TWO NEW STENTS WERE PUT IN THE LAD. RESUSCITATION WAS REQUIRED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14188308 ↗
• MalfunctionMar 15, 2022Positioning Problem; Positioning Problem

  PATIENT HAD AN ANEURYSMAL SAPHENOUS VEIN GRAFT. IT WAS DECIDED TO RECANALIZE THE NATIVE TOTAL OCCLUDED RCA. DURING TREATMENT A TYPE III PERFORATION OCCURRED IN THE RCA. TO STOP THE BLEEDING, A BALLOON DILATATION WAS PERFORMED BUT UNSUCCESSFULLY. AFTERWARDS, THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT, BUT THE STENT COULD NOT SEAL THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13765092 ↗
• MalfunctionMar 10, 2022Positioning Problem; Positioning Problem

  PATIENT HAD AN ANEURYSMAL SAPHENOUS VEIN GRAFT. IT WAS DECIDED TO RECANALIZE THE NATIVE TOTAL OCCLUDED RCA. DURING TREATMENT A TYPE III PERFORATION OCCURRED IN THE RCA. TO STOP THE BLEEDING, A BALLOON DILATATION WAS PERFORMED BUT UNSUCCESSFULLY. AFTERWARDS, THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT, BUT THE STENT COULD NOT SEAL THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726719 ↗
• DeathMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION IN THE PROXIMAL TO MID LAD. THE COMPLAINT PK PAPYRUS STENT DISLODGED FROM THE DELIVERY BALLOON INSIDE THE GUIDELINER. TWO OTHER PK PAPYRUS STENTS WERE IMPLANTED AND THE PERFORATION WAS SEALED SUCCESSFULLY. THE PATIENT PASSED AWAY DUE TO SHOCK, WHICH WAS CLASSIFIED BY THE HOSPITAL AS NOT DEVICE RELATED.

  Patient problems: Insufficient Information

  MAUDE report 13711135 ↗
• MalfunctionSep 9, 2021Positioning Problem; Positioning Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THERE WAS A PERFORATION ON A SAPHENOUS VEIN GRAFT WHICH COULD NOT BE SEALED AFTER PROLONGED BALLOON INFLATION. THE FIRST PK PAPYRUS 4.0 X 20 MM WAS DEPLOYED AT 12 ATM AND TWO MINUTES INFLATION. THIS DID NOT STOP THE BLEEDING. ANOTHER PK PAPYRUS WAS USED WHICH DID NOT SEAL EITHER (IS SUBMITTED SEPARATELY). A LONG 4.0 BALLOON WAS INFLATED FOR 25 MIN. THAT FINALLY SEALED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445584 ↗
• MalfunctionJan 12, 2021Use of Device Problem; Use of Device Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE 3 PERFORATION IN THE PROXIMAL RCA. THE PK PAPYRUS WAS UNABLE TO SEAL THE PERFORATION AT 18 ATM FOR 30 SECONDS. A SECOND PK PAPYRUS WAS THEN ATTEMPTED AND WAS ABLE TO SEAL THE PERFORATION. IT WAS REPORTED THAT THERE WAS NO DEVICE RELATED PROLONGATION OF STAY IN THE HOSPITAL OR INJURY RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156671 ↗
• InjuryJan 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LCX. DURING AN ACUTE MI THE VESSEL HAD A SMALL PERFORATION AFTER INITIAL PCI. WHEN GOING IN WITH THE PK PAPYRUS THE STENT DISLODGED FROM THE BALLOON. SEVERAL ATTEMPTS WERE MADE TO SNARE THE STENT BUT WERE UNSUCCESSFUL. PATIENT ENDED UP BEING TRANSFERRED TO EMERGENCY CABG. UF/IMPORTER REPORT # (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11135739 ↗
• MalfunctionSep 30, 2020Mechanical Problem; Mechanical Problem

  THE PK PAPYRUS COVERED STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A PERFORATION IN THE PROXIMAL LAD. THE STENT WAS IMPLANTED BUT APPEARED TO HAVE A TEAR/LEAK. A SECOND PK PAPYRUS STENT WAS IMPLANTED AND SEALED THE PERFORATION SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10606221 ↗
• InjuryMar 31, 2020Mechanical Problem; Mechanical Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATED VESSEL. 2 TO 3 HOURS AFTER TREATMENT PATIENT WAS IN TAMPONADE. DRAINS WERE INSERTED TO RELIEVE PRESSURE. BALLOONED PROXIMAL AREA WAS STILL LEAKING. THE PK PAPYRUS 4.0/20 WAS DEPLOYED, STILL SOME LEAKAGE AND IT WAS CONTINUED TO DRAIN. PATIENT WAS DISCHARGED HOME NEXT DAY AND IS WELL.

  Patient problems: Cardiac Tamponade

  MAUDE report 9908663 ↗
• 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 9531416 ↗
• MalfunctionAug 22, 2019Inflation Problem; Inflation Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING THE PROCEDURE IT WAS NOT POSSIBLE TO INFLATE THE BALLOON OF THE PK PAPYRUS STENT SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923077 ↗