PK Papyrus 3.0/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07640130447165), received between Jul 1, 2019 and Feb 27, 2026 — classified as 6 deaths, 6 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Device Dislodged or Dislocated

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A PERFORATION IN THE LCX. THE STENT CAME OFF WHILE ADVANCING INTO THE BODY. AS IT COULD NOT BE VISUALIZED, ANOTHER PK PAPYRUS STENT WAS ATTEMPTED TO BE IMPLANTED BUT COULD NOT CROSS (REPORTED SEPARATELY). WHEN REMOVING THE SECOND DEVICE, THE DISLODGED STENT CAME OUT OF THE BODY TOGETHER WITH THE SECOND DEVICE. THE PERFORATION COULD BE SEALED WITH ANOTHER PK PAPYRUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466610 ↗
• MalfunctionFeb 27, 2026Failure to Advance

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A PERFORATION IN THE LCX. THE FIRST PK PAPYRUS US STENT (REPORTED SEPARATELY) CAME OFF WHILE ADVANCING INTO THE BODY. AS IT COULD NOT BE VISUALIZED, A SECOND PK PAPYRUS STENT (COMPLAINT DEVICE) WAS ATTEMPTED TO BE IMPLANTED BUT IT COULD NOT CROSS. WHEN REMOVING THE COMPLAINT DEVICE, THE DISLODGED FIRST STENT CAME OUT OF THE BODY TOGETHER WITH THE COMPLAINT DEVICE. THE PERFORATION COULD BE SEALED WITH ANOTHER PK PAPYRUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466609 ↗
• MalfunctionFeb 11, 2026Material Deformation; Material Split, Cut or Torn

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER INSERTION OF THE PK PAPYRUS THE PATIENT BEGAN TO CODE, AND THE DEVICE COULD NOT BE DELIVERED AS IT WAS NECESSARY TO PERFORM 3 ROUNDS OF CPR. UPON WITHDRAWAL, IT SEEMED LIKE THE COVER CAME OFF THE STENT SYSTEM. IVUS WAS PERFORMED BUT THE COVER COULD NOT BE LOCATED. THUS, THE LESION WAS BALLOONED AGAIN IN CASE THE COVER HAD BEEN LEFT INSIDE THE LESION TO TRAP IT AGAINST THE VESSEL WALL.

  Patient problems: Insufficient Information

  MAUDE report 24311976 ↗
• DeathMay 19, 2025Lack of Effect; Lack of Effect

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION (15 MM LENGTH) OCCURRED DURING POST-DILATATION OF A DES. AFTER THE FIRST PK PAPYRUS (COMPLAINT DEVICE) WAS PLACED, THE PERFORATION WAS NOT COMPLETELY SEALED SO A SECOND PK PAPYRUS WAS DEPLOYED. A POSSIBLE EDGE DISSECTION AT THE EDGE OF THE SECOND STENT SUSPECTED (REPORTED SEPARATELY), SO AN ONYX FRONTIER WAS DEPLOYED. AFTERWARDS, AN IMPELLA WAS PLACED AND THE PATIENT LEFT CATH LAB TO ICU. PATIENT CONTINUED TO HAVE SEVERE HEMODYNAMIC COMPROMISE DESPITE INCREASING MECHANICAL SUPPORT. FAMILY ULTIMATELY DECIDED TO WITHDRAW CARE. ADDITIONAL PATIENT CODE E0504.

  Patient problems: Cardiac Tamponade

  MAUDE report 22044301 ↗
• MalfunctionMar 18, 2025Fluid/Blood Leak; Failure to Advance; Fluid/Blood Leak; Failure to Advance

  GRADE 4 PERFORATION HAD OCCURRED. PERICARDIOSCENTESIS 900ML PERFORMED. THE COMPLAINT PK PAPYRUS COVERED STENT SYSTEM WAS ADVANCED BUT WAS UNABLE TO CROSS ANATOMY WITH BUDDY WIRE TECHNIQUE AND 6F GUIDELINER. A LEAK WAS IDENTIFIED AT HUB OF PAPYRUS AND DEVICE WAS REMOVED AND DISCARDED. LIKELY BROKEN SHAFT FROM CATHETER MANIPULATION. TWO OTHER PK PAPYRUS WERE IMPLANTED AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21633450 ↗
• MalfunctionFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE DISTAL RCA. AFTER IMPLANTING A FIRST PK PAPYRUS STENT, IT WAS ATTEMPTED TO PLACE A 2ND ONE, BUT THE 2ND STENT DISLODGED FROM BALLOON IN MID RCA AND REMAINS. THE STENT WAS ADAPTED TO THE VESSEL WALL WITH A DES STENT. ANOTHER PK PAPYRUS STENT WAS DEPLOYED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21434685 ↗
• MalfunctionJul 25, 2024Inflation Problem; Inflation Problem

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. THIS DEVICE DID NOT INFLATE. IT WAS REMOVED INTACT. ANOTHER PK PAPYRUS WAS USED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826977 ↗
• InjuryJan 23, 2024Lack of Effect; Lack of Effect

  TWO PK PAPYRUS COVERED STENT SYSTEM WERE SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE PROXIMAL LCX. THE 3.0/15 PK PAPYRUS (CURRENT DEVICE) WAS DEPLOYED FIRST, BUT ANGIOGRAPHY STILL SHOWED EXTRAVASATION. POST-DILATATION WAS PERFORMED, AND A SECOND PK PAPYRUS WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, THE SECOND 2.5/15 PK PAPYRUS (REPORTED SEPARATELY) WAS NOT ABLE TO PASS DISTALLY INTO THE LEFT CIRCUMFLEX TO OVERLAP APPROPRIATELY AND IT WAS REMOVED FROM THE BODY. DURING REMOVAL THE STENT COVER FELL OFF AND WAS TRAPPED WITHIN THE TUOHY. THE TUOHY WAS DISCONNECTED, AND THE STENT WAS REMOVED MECHANICALLY. PATIENT WAS TRANSFERRED TO ICU TO BE OBSERVED OVERNIGHT AND WAS DISCHARGED HOME ON (B)(6) 2023.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18567262 ↗
• 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 THIRD OF THREE PK PAPYRUS COVERED STENTS THAT FAILED TO SEAL IN THE MID LAD. EACH IS REPORTED SEPARATELY.

  Patient problems: Insufficient Information

  MAUDE report 17735880 ↗
• MalfunctionJul 14, 2023Failure to Advance; Failure to Advance

  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 3RD PK PAPYRUS. THE OTHER TWO PKPS ARE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325561 ↗
• MalfunctionApr 18, 2023Lack of Effect; Lack of Effect

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION IN THE MID LAD. THE STENT DID NOT SEAL AND LEAKED AFTER PLACEMENT. AN ADDITIONAL OVERLAPPING PK PAPYRUS STENT WAS IMPLANTED. THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763094 ↗
• MalfunctionDec 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIALLY, A WRONG LOT NUMBER AND SIZE (LOT 02192475 / PK PAPYRUS US 3.0/20) WAS REPORTED ON MDR (B)(4). AFTER CLARIFICATION, IT COULD BE SHOWN THAT IN THE PK PAPYRUS SIZE 3.0/15 ONLY ONE LOT (03216395) WAS EVER DELIVERED TO THE RESPECTIVE HOSPITAL AND WAS DEFINED AS THE COMPLAINT LOT. MULTIPLE PASSES WITH ROTAPRO (ROTATIONAL ATHERECTOMY) DUE TO SEVERELY CALCIFICATION (60 PERCENT STENOSIS DEGREE) LEAD TO TYPE III PERFORATION OF PROXIMAL TO MID LAD. THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE PERFORATION. INITIALLY, IT WAS TRIED A BLOCK-AND-DELIVER TECHNIQUE (PLACED A SECOND WIRE, BMW) INTO THE DISTAL LAD, AND OVER THIS TRIED TO DELIVER THE PK PAPYRUS, BUT THIS STRIPPED OFF. THE STENT COULD BE RETRIEVED. THREE OTHER PK PAPYRUS STENTS WERE IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931533 ↗
• MalfunctionSep 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT TYPE III CS/IV PERFORATION IN THE DISTAL LCX. THE PK PAPYRUS STENT DISLODGED FROM THE BALLOON INSIDE THE GUIDING CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENTS BODY AND ANOTHER PK PAPYRUS STENT WAS USED. THE PERFORATION WAS SEALED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417274 ↗
• InjurySep 1, 2022Failure to Advance; Failure to Advance

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE DISTAL RCA. THIS IS THE FIRST OF TWO PK PAPYRUS USED. (THE SECOND DEVICE IS REPORTED SEPARATELY). PATIENT ENTERED PROCEDURE WITH ST ELEVATION AND PROFOUND CARDIOGENIC SHOCK. A STENT WAS PLACED IN THE MID SEGMENT AND A PERFORATION WAS DETECTED. IT WAS NOT POSSIBLE TO ADVANCE THE PK PAPYRUS DISTALLY ENOUGH TO COVER THE PERFORATION. EMERGENT CABG WAS DONE, AND AN INTRA-AORTIC BALLOON PUMP (IABP) WAS IMPLANTED, BUT IT WAS NOT POSSIBLE TO WEAN THE PATIENT FROM THE CARDIOPULMONARY BYPASS. DESPITE MAX. EFFORTS, PATIENT EXPIRED.

  Patient problems: Cardiogenic Shock

  MAUDE report 15339262 ↗
• MalfunctionJul 29, 2022Break; Break

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID RCA. THE STENT WAS NOT IMPLANTED BECAUSE IT BROKE DURING DELIVERY. THE PERFORATION WAS SUCCESSFULLY SEALED WITH TWO OTHER PK PAPYRUS STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130471 ↗
• MalfunctionMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION IN PROXIMAL RCA AT THE TARGET LESION. THE PK PAPYRUS WAS INSERTED, BUT UNABLE TO CROSS, AND THE STENT DISLODGED. ANOTHER PK PAPYRUS WAS USED AND SUCCESSFULLY DEPLOYED. THE PERFORATION WAS SEALED AND NO INJURY OR COMPLICATIONS TO PATIENT HAD OCCURRED. PATIENT WAS DISCHARGED AS USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943143 ↗
• DeathMar 15, 2022Positioning Problem; Positioning Problem

  AN ATHERECTOMY AT LOW SPEED WAS PERFORMED WHEN A LARGE PERFORATION IN THE MID LAD WAS DETECTED. BALLOONING AND A PERICARDIOCENTESIS DRAINING WAS PERFORMED. TWO PK PAPYRUS COVERED STENTS WERE IMPLANTED, BUT THE BLEEDING EXTENDED DOWN FURTHER IN THE LAD. THE PATIENT WAS INTUBATED AND AN IMPELLA WAS PLACED, BUT THE BLEEDING DID NOT STOP. THE LAD WAS COILED WITH MULTIPLE PENUMBRA COILS. THE PATIENT STABILIZED AND THE BLEEDING WAS RESOLVED. PATIENT LEFT ON IMPELLA AND INTUBATED. PATIENTS FAMILY DECLINED FURTHER CARE IN ICU. TWO DAYS AFTER THE INTERVENTION THE PATIENT PASSED AWAY. OTHER PK PAPYRUS STENT IS REPORTED SEPARATELY.

  Patient problems: Cardiogenic Shock

  MAUDE report 13765117 ↗
• DeathMar 14, 2022Positioning Problem; Positioning Problem

  AN ATHERECTOMY AT LOW SPEED WAS PERFORMED WHEN A LARGE PERFORATION IN THE MID LAD WAS DETECTED. BALLOONING AND A PERICARDIOCENTESIS DRAINING WAS PERFORMED. TWO PK PAPYRUS COVERED STENTS WERE IMPLANTED, BUT THE BLEEDING EXTENDED DOWN FURTHER IN THE LAD. THE PATIENT WAS INTUBATED AND AN IMPELLA WAS PUT IN THE LEFT COMMON FEMORAL ARTERY, BUT THE BLEEDING DID NOT STOP. THE LAD WAS COILED WITH MULTIPLE PENUMBRA COILS. THE PATIENT STABILIZED AND THE BLEEDING WAS RESOLVED. PATIENT LEFT ON IMPELLA AND INTUBATED. PATIENTS FAMILY DECLINED FURTHER CARE IN ICU. TWO DAYS AFTER THE INTERVENTION THE PATIENT PASSED AWAY. OTHER PK PAPYRUS STENT IS REPORTED SEPARATELY.

  Patient problems: Cardiogenic Shock

  MAUDE report 13757592 ↗
• DeathMar 9, 2022Positioning Problem; Positioning Problem

  AFTER ATHERECTOMY AND BALLOON DILATATION A PERFORATION HAD OCCURRED IN THE MID LAD. THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT, BUT THE STENT FAILED TO SEAL THE WHOLE PERFORATION. THE CODE STATUS CHANGED TO DNR (DO NOT RESUSCITATE). THE PATIENT PASSED AWAY THE SAME DAY. THE HOSPITAL STATED THAT THIS A PROCEDURE-RELATED COMPLICATION AND NOT DEVICE RELATED. THEY HAVE BEEN UNWILLING TO PROVIDE ANY FURTHER DETAILS.

  Patient problems: Failure of Implant

  MAUDE report 13703547 ↗
• 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 REPORTED SEPARATELY. FINALLY, THE PERFORATION WAS TREATED WITH COILS.

  Patient problems: Insufficient Information

  MAUDE report 13367493 ↗
• MalfunctionNov 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT FELL OFF THE BALLOON PRIOR TO INSERTION. ANOTHER PK PAPYRUS WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804836 ↗
• InjuryOct 19, 2021Leak/Splash; Leak/Splash

  AFTER PRE-DILATATION OF A DISTAL STENOTIC RIGHT CORONARY VEIN GRAFT LESION AND BARE METAL STENT DEPLOYMENT, ANGIOGRAPHIC VISUALIZATION REVEALED A TYPE II PERFORATION IN DISTAL RCA. THE PK PAPYRUS COVERED STENT WAS DEPLOYED FOLLOWED BY ANOTHER POST-DILATATION AND SUCCESSFUL DEPLOYMENT OF ANOTHER BARE METAL STENT. HOWEVER, POST ANGIOGRAPHIC VISUALIZATION REVEALED PERICARDIAL BLUSH IN SAME AREA WHERE THE PK PAPYRUS WAS DEPLOYED. SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 12656354 ↗
• MalfunctionMar 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. WHILE REMOVING THE PK PAPYRUS FROM ITS PACKAGE, THE STENT STRIPPED OFF THE DELIVERY SYSTEM. ANOTHER PK PAPYRUS WAS USED TO SEAL THE PERFORATION SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11457278 ↗
• MalfunctionMar 10, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. SEVERAL ATTEMPTS TO CROSS THE LESION WERE MADE BUT THE PK PAPYRUS COULD NOT CROSS. UPON REMOVAL AND EXAMINATION THE PK PAPYRUS STENT WAS NOTICED TO BE SHIFTED TOWARDS TO THE TIP OF THE CATHETER AND MAY HAVE BEEN SLIGHTLY DEFORMED. THIS WAS ORIGINALLY REPORTED ON MDR-1028232-2021-00873, BUT THE LOT NUMBER WAS INCORRECT. WE HAVE CLOSED THAT REPORT AND ARE OPENING THIS IN ITS PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453931 ↗
• MalfunctionFeb 19, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. SEVERAL ATTEMPTS TO CROSS THE LESION WERE MADE BUT THE PK PAPYRUS COULD NOT CROSS. UPON REMOVAL AND EXAMINATION THE PK PAPYRUS STENT WAS NOTICED TO BE SHIFTED TOWARDS TO THE TIP OF THE CATHETER AND MAY HAVE BEEN SLIGHTLY DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350989 ↗