PK Papyrus 3.0/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07640130447271), received between Jul 1, 2019 and Aug 27, 2026 — classified as 5 deaths, 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Failure to Advance

  The PK Papyrus covered stent system was selected for treatment of a lesion in the mid LAD. The device was inserted into the patient's body but could not pass the lesion. The procedure was finished using a smaller PK Papyrus.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50469876 ↗
• MalfunctionDec 5, 2025Failure to Advance; Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE LM TO PROXIMAL LAD (NO FURTHER INFORMATION AVAILABLE) BY ORBITAL ATHERECTOMY DURING WHICH A CORONARY ARTERY PERFORATION OCCURRED. THE ORBITAL ATHERECTOMY WIRE SHEARED IN HALF WITH THE DISTAL PORTION OF THE WIRE REMAINING IN THE MID TO DISTAL LAD. THE TWO AFFECTED PK PAPYRUS (THE 1ST DEVICE WAS REPORTED SEPARATELY) WERE INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727004 ↗
• 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 THREE 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 23153737 ↗
• InjurySep 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS INTENDED TO TREAT A LESION IN THE MID LAD WITH A BALLOON DURING WHICH A CORONARY ARTERY PERFORATION TYPE II (PERFORATION LENGTH 18 MM) OCCURRED. THE PK PAPYRUS COVERED STENT WAS SUCCESSFULLY IMPLANTED WITH 13 ATM. HOWEVER, IVUS DEMONSTRATED AN INADEQUATELY APPOSED STENT WHICH WAS THEN POST-DILATED WITH TWO NC BALLOON. IN ADDITION, AN ONYX STENT WAS IMPLANTED IN THE PROXIMAL LAD OVERLAPPING THE PK PAPYRUS. POST-DILATION WAS AGAIN PERFORMED WITH AN NC MM BALLOON. SUBSEQUENT ANGIOGRAPHY REVEALED A SMALL DISTAL STENT EDGE DISSECTION DISTAL TO THE COVERED STENT WHICH WAS TREATED WITH AN ONYX STENT WHICH WAS AGAIN IMPLANTED IN AN OVERLAPPING MANNER. FINAL ANGIOGRAPHY SHOWED POST-PROCEDURAL TIMI-3 FLOW WITH NO COMPROMISE OF SIDE BRANCHES AND SMALL DISTAL WIRE PERFORATION THAT RESOLVED WITH REPEATED ANGIOGRAPHY.

  Patient problems: Vascular Dissection

  MAUDE report 22949553 ↗
• MalfunctionMar 20, 2025Failure to Advance; Failure to Advance

  DURING LITHOTRIPSY A PERFORATION HAD OCCURRED IN THE MID LAD. AFTER SUCCESSFUL PLACEMENT OF THE PK PAPYRUS COVERED STENT, A COMPETITORS DES WAS ATTEMPTED TO BE IMPLANTED BUT STRIPPED OFF BALLOON. ATTEMPTS WERE MADE TO DELIVER SMALL BALLOONS WITHIN THE STRIPPED STENT BUT NOTHING WAS ABLE TO PASS THROUGH THE STENT. IT APPEARED THIS RESULTED IN THE STENT BUNCHING WITHIN THE MIDDLE OF THE PKP. PATIENT REQUIRED EMERGENT CABG.

  Patient problems: Cardiac Tamponade

  MAUDE report 21655671 ↗
• MalfunctionNov 21, 2023Material Deformation; Material Deformation

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PROXIMAL VESSEL. THE PROXIMAL EDGE OF THE STENT FLARED DUE TO CALCIFICATION. THE STENT WAS REMOVED, AND ANOTHER PK PAPYRUS WAS OPENED AND WAS USED TO REPAIR THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188714 ↗
• MalfunctionSep 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PKP WAS INTENDED TO TREAT A LESION IN THE LMCA / PROXIMAL LCX / PROXIMAL LAD WITH TWO BALLOONS AND TWO STENTS DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. IT WAS UNCLEAR WHERE THE PERFORATION ORIGINATED GIVEN THE SHORT LM AND EXTREME VESSEL TORTUOSITY OVERLAP, BUT BALLOON INFLATION IN THE LAD APPEARED TO STOP THE BLEEDING. TWO PK PAPYRUS COVERED STENTS WERE ATTEMPTED TO BE IMPLANTED BUT BOTH DISLODGED. THEY WERE REMOVED FROM THE BODY. OTHER PK PAPYRUS COVERED STENTS WERE IMPLANTED AND THE PERFORATION WAS SUCCESSFULLY SEALED. THE TREATING PHYSICIAN RATED THE OCCURRENCE AS BOTH NO DEVICE- AND NO PROCEDURE-RELATED COMPLICATION. THIS REFERS TO THE SECOND PK PAPYRUS. THE FIRST IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778021 ↗
• MalfunctionJul 10, 2023Failure to Advance; Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION IN 1ST OBSTRUSE MARGINAL ARTERY OCCURRED DURING DES IMPLANTATION. THE PK PAPYRUS STENT CAME OFF BALLOON PRIOR TO DEPLOYMENT (FILED SEPARATELY). STENT NOTED TO NOT BE ON BALLOON AFTER REMOVED FROM PATIENT. THE STENT WAS LOCATED IN THE GUIDE CATHETER AND REMOVED UNDEPLOYED AND INTACT. THE SECOND PK PAPYRUS STENT (COMPLAINT DEVICE) WOULD NOT PASS DUE TO TORTUOSITY OF THE VESSEL AND HAD TO BE REMOVED. SUBSEQUENTLY, THE PERFORATION WAS SUCCESSFULLY SEALED WITH 5 MIN BALLOON DILATATION. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17292133 ↗
• MalfunctionJun 22, 2023Material Deformation; Material Deformation

  A PULSAR-18 SELF-EXPANDABLE STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. THE COVERED STENT GOT STUCK IN THE BACK OF THE GUIDEZILLA CATHETER AND COULD NOT BE ADVANCED. IT GOT DAMAGED. THREE OTHER PK PAPYRUS STENTS WERE IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183264 ↗
• 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 16935396 ↗
• MalfunctionMay 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 16934973 ↗
• MalfunctionMar 16, 2023Lack of Effect; Lack of Effect

  AFTER PRE-DILATATION OF THE LESION IN THE MID LAD A TYPE III PERFORATION HAD OCCURRED. THE PK PAPYRUS COVERED STENT WAS DEPLOYED, BUT THERE WAS A PERSISTENT LEAK, SO A SECOND PK PAPYRUS COVERED STENT WAS DEPLOYED OVERLAPPING. ECHOCARDIOGRAPHY DEMONSTRATED NO FREE-FLOWING EFFUSION. PATIENT IS DOING WELL. HEMODYNAMICS IS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553067 ↗
• MalfunctionMar 7, 2023Lack of Effect; Lack of Effect

  TWO TYPE III PERFORATIONS IN THE RCA HAD OCCURRED. THE OSTIAL/PROXIMAL PERFORATION WAS SUCCESSFULLY TREATED WITH PK PAPYRUS COVERED STENT 4.5/20. THE DISTAL PERFORATION WAS TREATED WITH THE PK PAPYRUS 3.0/26, WHICH DID NOT SEAL, SO A PK PAPYRUS 2.5/20 WAS OVERLAPPING DISTALLY IMPLANTED. FINALLY, BOTH PERFORATIONS WERE SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497495 ↗
• MalfunctionDec 13, 2022Malposition of Device; Malposition of Device

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS DISTAL LCX, DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. THE PK PAPYRUS 3.0/26 WAS FIRST IMPLANTED, BUT NOT AT THE CORRECT POSITION. THEREFORE, A PK PAPYRUS 3.0/15 WAS IMPLANTED OVERLAPPING WITH THE FIRST PK PAPYRUS STENT TO FINALLY SEAL THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970874 ↗
• DeathNov 16, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER PLACING A STENT IN THE MID LAD IN A PRE-DILATED TOTAL OCCLUSION AND SUBSEQUENTLY PERFORMED POST DILATATION, A TYPE III PERFORATION WAS DETECTED. THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PERFORATION. THE PERFORATION WORSENED AFTER BALLOON DILATION AND PK PAPYRUS DEPLOYMENT. THE TEAR WAS EXTENDED IN BOTH DIRECTIONS, PROXIMALLY AND PREDOMINANTLY DISTAL TO THE VESSEL. CARDIAC TAMPONADE AND PEA ARREST OCCURRED. ATTEMPTED ECMO PLACEMENT, WITHOUT SUCCESS. PATIENT EXPIRED IN THE CATH LAB.

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 15811551 ↗
• DeathNov 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AFTER PLACING A STENT IN THE MID LAD IN A PRE-DILATED TOTAL OCCLUSION AND SUBSEQUENTLY PERFORMED POST DILATATION, A TYPE III PERFORATION WAS DETECTED. THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PERFORATION. THE PERFORATION WORSENED AFTER BALLOON DILATION AND PK PAPYRUS DEPLOYMENT. THE TEAR WAS EXTENDED IN BOTH DIRECTIONS, PROXIMALLY AND PREDOMINANTLY DISTAL TO THE VESSEL. CARDIAC TAMPONADE AND PEA ARREST OCCURRED. ATTEMPTED ECMO PLACEMENT, WITHOUT SUCCESS. PATIENT EXPIRED IN THE CATH LAB.

  Patient problems: Cardiac Arrest; Cardiac Tamponade

  MAUDE report 15798387 ↗
• MalfunctionMay 6, 2022Positioning Problem; Positioning Problem

  THE PK PAPYRUS WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE LAD. DURING TREATMENT OF A TYPE II PERFORATION IN THE MID LAD, THE STENT WAS IMPLANTED BUT DID NOT PROPERLY SEAL THE PERFORATION. A 2ND PK PAPYRUS WAS USED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14303732 ↗
• MalfunctionFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. THE STENT CAME OFF THE DELIVERY SYSTEM BEFORE THE PROCEDURE, OUTSIDE PATIENTS BODY. ANOTHER PK PAPYRUS WAS USED TO SUCCESSFULLY COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480839 ↗
• MalfunctionJan 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE LCX. DURING THE ATTEMPT TO SEAL THE PERFORATION THE STENT DISLODGED FROM THE BALLOON. ANOTHER PK PAPYRUS STENT WAS USED BUT ALSO DISLODGED AND IS SEPARATELY REPORTED. FINALLY, THE PERFORATION WAS TREATED WITH COILS.

  Patient problems: Insufficient Information

  MAUDE report 13367490 ↗
• MalfunctionNov 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION, WHICH OCCURRED DURING ORBITAL ATHERECTOMY IN THE CX. THE DEVICE COULD NOT BE ADVANCED THROUGH LEFT MAIN INTO THE CX. THE STENT DISLODGED. TWO OTHER PK PAPYRUS WERE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 12787407 ↗
• DeathSep 30, 2020Use of Device Problem; Use of Device Problem

  IT WAS ATTEMPTED TO TREAT A PERFORATION WITH THE PK PAPYRUS STENT SYSTEM BUT IT DID NOT SEAL THE DISTAL PERFORATION PROPERLY. THUS ANOTHER STENT WAS DEPLOYED INSIDE THE PK PAPYRUS AND SEALED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10606228 ↗
• DeathSep 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION WHICH OCCURRED ONE DAY BEFORE. DURING PROCEDURE IT SEEMED THAT THE STENT WAS DISPLACED ON THE DELIVERY SYSTEM AND THEREFORE THE DEVICE WAS REMOVED FROM PATIENTS BODY. THERE WAS NO ATTEMPT TO DEPLOY THE DEVICE AND IT HAD NO EFFECT ON THE PROCEDURE. ANOTHER PK PAPYRUS WAS INSERTED. PATIENT PASSED AWAY 2 HOURS AFTER INTERVENTION. IT WAS STATED BY THE HOSPITAL STAFF THAT THE DEATH WAS NOT DEVICE RELATED.

  Patient problems: Death

  MAUDE report 10482834 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PK PAPYRUS US COVERED STENT SYSTEM WAS CHOSEN TO SEAL A VERY LARGE PERFORATION. THE PERFORATION WHICH OCCURRED ON A GIANT PIECE OF CALCIUM HIT WITH A ROTABLATOR WAS IN THE PROXIMAL LAD IN A VESSEL THAT IS OCCLUDED MID LAD AND IN A DIAGONAL, SUPPLYING MANY SEPTALS OF THE RCA TO SEAL THE PERFORATION BIFURCATION STENTING WAS DONE, BUT THE LAD PERFORATION WAS NOT FULLY COVERED BY THE 2ND PK PAPYRUS PLACED FROM LM INTO THE LAD. THEREFORE 3RD WAS PLACED LEFT MAIN INTO CX. DUE TO COVERING THE LAD WHICH WAS NECESSARY TO SEAL AND SURVIVE THE PERFORATION THE PATIENT HAD A PROCEDURAL MYOCARDIAL INFARCTION. ALL THREE PK PAPYRUS US STENTS WERE PROPERLY DEPLOYED. THERE WAS NO MALFUNCTION OF THE DEVICE. IT IS NOT KNOWN WHICH OF THE THREE PLACED PK PAPYRUS US, WHICH HAD TO BE PLACED DURING THE INTERVENTION TO SAVE THE PATIENTS LIFE, POSSIBLY LED TO PROCEDURAL MYOCARDIAL INFARCTION. 3 STENTS REPORTED ON MDR-1028232-2020-02866, AND MDR-1028232-2020-02868.

  Patient problems: Myocardial Infarction

  MAUDE report 10273863 ↗
• MalfunctionJul 8, 2020Failure to Advance; Failure to Advance

  THE PK PAPYRUS US COVERED STENT SYSTEM WAS CHOSEN TO SEAL A PERFORATION THE LAD. THE DEVICE COULD NOT PASS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10248346 ↗
• DeathJul 1, 2019Entrapment of Device; Entrapment of Device

  THE PK PAPYRUS US COVERED STENT SYSTEM WAS SELECTED FOR USE TO TREAT A DISSECTION. THE PK PAPYRUS US WAS STRIPPED OFF THE PROXIMAL COLLAR OF A GUIDEZILLA. IT WAS DISCOVERED THAT THE STENT WAS NO LONGER ON THE BALLOON AFTER REMOVAL OF THE GUIDE SYSTEM. THE PHYSICIAN SUSPECTS THAT THE STENT WAS PULLED OFF WHEN ADVANCING THE STENT INSIDE THE GUIDEZILLA. 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 8750615 ↗