PK Papyrus 2.5/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 07640130447158), received between Jul 1, 2019 and Sep 9, 2026 — classified as 12 deaths, 13 injuries, 71 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (63 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Device Dislodged or Dislocated

  The PK Papyrus covered stent was selected for treatment of a type III perforation in the proximal LCx. After balloon dilatation was performed to stop the bleeding, an attempt was made to advance the PK Papyrus to the lesion, but even after several attempts, it was not possible to pass the lesion. When removing the device, it was noticed that there was no outer coating on the stent anymore. The perforation was successfully sealed using another PK Papyrus.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50685923 ↗
• MalfunctionApr 29, 2026Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN ELLIS TYPE I PERFORATION IN THE MID LAD. THE PERFORATION OCCURRED DURING IMPLANTATION OF A DES. AFTER BALLOON DILATATION. IT WAS ATTEMPTED TO ADVANCE THE COMPLIANT DEVICE BUT THIS WAS COMPLICATED BY THE STENT COMING OFF THE BALLOON. THE STENT WAS NEVER DEPLOYED AND REMAINED ON THE GUIDEWIRE AT THE TIP OF THE GUIDING CATHETER. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SENT WITH A GOOSENECK SNARE BUT WERE UNSUCCESSFUL. FINALLY, IT WAS DECIDED TO PUSH THE STENT BACK INT THE LAD. EVENTUALLY TWO DES WERE DEPLOYED IN THE PROXIMAL TO MID LAD ADAPTING THE UNDEPLOYED COVERED STENT INTO THE VESSEL WALL. EXCELLENT RESULTS WERE ACHIEVED IN THE LAD WITH TIMI 3 FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031070 ↗
• MalfunctionApr 29, 2026Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN ELLIS TYPE III PERFORATION IN THE DISTAL LAD. THE PERFORATION OCCURRED DURING IMPLANTATION OF A DES. AFTER PROTAMINE WAS GIVEN AND BALLOON DILATATION WAS PERFORMED, THE PK PAPYRUS WAS INTRODUCED, BUT IT WAS DIFFICULT TO DELIVER THE DEVICE TO THE DISTAL LAD. DURING ATTEMPT TO DELIVER, THE WIRE CAME BACK, WAS READVANCED AND THEN ABLE TO DELIVER THE PK PAPYRUS SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027052 ↗
• MalfunctionMar 3, 2026Failure to Advance; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN A SIDE BRANCH OF THE RCA. AFTER PROTAMINE INJECTION, BALLOON DILATATION AND UNSUCCESSFUL COIL DELIVERY, THE COMPLAINT PK PAPYRUS WAS INTRODUCED BUT UNABLE TO BE DELIVERED. LATER, ON TABLE, THE STENT STRIPPED OFF BALLOON. SO, IT WAS DISCARDED. ANOTHER PK PAPYRUS WAS USED, AND THE LESION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495173 ↗
• MalfunctionDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER BALLOON DILATATION IN THE MAIN BRANCH OF THE LAD A TYPE III PERFORATION OCCURRED. BALLOON DILATATION WAS PERFORMED TO STOP BLEEDING AND THEN, IT WAS DECIDED TO IMPLANT A PK PAPYRUS COVERED STENT. THE DEVICE FAILED TO DELIVER TO MID LAD BECAUSE IT GOT TRAPPED BY A DES IN LM AND DISLODGED. ADDITIONAL BALLOON TAMPONADE WAS PERFORMED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23753983 ↗
• MalfunctionOct 16, 2025Fracture; Fracture

  A PK PAPYRUS COVERED STENT WAS SELECTED FOR TREATMENT. IT WAS REPORTED THAT THE STENT WIRE SNAPPED IN TWO PARTS WHILE TRYING TO CROSS OVER. ADDITIONAL INFORMATION RECEIVED: DURING ORBITAL ATHERECTOMY OF A HEAVILY CALCIFIED LM-PROXIMAL LAD LESION, A CORONARY PERFORATION OCCURRED AND THE ATHERECTOMY WIRE SHEARED, LEAVING ITS DISTAL PORTION IN THE LAD. TWO PK PAPYRUS DEVICES (CPIDS 25111402 & 25111403) COULD NOT CROSS THE LESION. DURING A FURTHER ATTEMPT, THE PK PAPYRUS HYPOTUBE FRACTURED OUTSIDE THE PATIENT'S BODY, WITH NO RESISTANCE REPORTED DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308236 ↗
• MalfunctionOct 15, 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 TYPE II PERFORATION IN THE MID RCA. THE DEVICE COULD NOT BE DELIVERED AND THEN THE STENT GOT LOST. THE STENT COULD NOT BE FOUND, NEITHER INSIDE NOR OUTSIDE PATIENT'S BODY. ANOTHER PK PAPYRUS WAS IMPLANTED IN AN ADDITIONAL INTERVENTION. THE PHYSICIAN RATED THE EVENT AS DEVICE RELATED COMPLICATION.

  Patient problems: Insufficient Information

  MAUDE report 23277975 ↗
• 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 ONE 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 23153401 ↗
• MalfunctionSep 22, 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 IN THE MID LCX. AFTER BALLOON TAMPONADE WAS PERFORMED, THE PK PAPYRUS WAS INTRODUCED BUT COULD NOT CROSS THE LESION AND WAS WITHDRAWN. DURING THE ATTEMPT TO EXCHANGE IT, THE STENT DISLODGED WITHIN THE EXTENSION CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23107953 ↗
• MalfunctionJul 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS INTENDED TO TREAT A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS PART OF THE MID LAD (70-80 % STENOSIS DEGREE) WITH A DES STENT DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. TO STOP THE BLEEDING, BALLOON DILATION WAS PERFORMED, FOLLOWED BY PERICARDIOCENTESIS. THE AFFECTED PK PAPYRUS 2.5/15 WAS THEN INTRODUCED INTO THE PATIENT'S BODY, BUT THE STENT DISLODGED FROM THE BALLOON. HOWEVER, THE DISLODGED STENT COULD BE DILATED INSIDE THE PREVIOUSLY IMPLANTED STENT. THEREAFTER, A PK PAPYRUS 2.5/15 WAS DEPLOYED DISTALLY TO THE FIRST STENT WITH COMPLETE SEALING OF THE TEAR. EVENTUALLY, THE STENTS WERE POST-DILATED WITH A 3.0 NC BALLOON. THE MORE PROXIMAL PORTION OF THE LAD ALSO APPEARED TO HAVE SEVERE DISEASE, LIKELY WORSENED BY THE EXTENSION CATHETER DUE TO WHICH A DES 3.0/12 MM STENT WAS IMPLANTED OVERLAPPING THE OTHER STENTS. FOLLOWING POST DILATATION, FLOW WAS LOST IN THE JAILED D2 AT WHICH THE PHYSICIAN WAS UNABLE TO REGAIN ACCESS. THE D1 WAS ALSO JAILED BUT COULD BE REWIRED AND DILATED THROUGH THE STENT STRUTS WITH A GOOD FINAL RESULT. IVUS WAS USED FOR PROCEDURAL GUIDANCE. AFTER AN ADDITIONAL TREATMENT OF A RAMUS LESION, THE PATIENT WAS ADMITTED TO MICU FOR

  Patient problems: Pain; Pericardial Effusion

  MAUDE report 22435101 ↗
• MalfunctionApr 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING TREATMENT OF THE MID LAD WITH A BALLOON, A TYPE III PERFORATION HAD OCCURRED. AFTER PLACING THE 1ST PK PAPYRUS COVERED STENT, IT WAS ATTEMPTED TO IMPLANT A 2ND PK PAPYRUS STENT, BUT THE DEVICE WAS UNABLE TO CROSS THE LESION, AND THE COVERING OF PAPYRUS STENT WAS STRIPPED IN THE ENTRANCE TO 6F GUIDELINER. THE 2ND PK PAPYRUS STENT WAS NEVER DEPLOYED IN PATIENT. THEN, A BALLOON WAS USED TO TREAT THE PERFORATION. THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937893 ↗
• MalfunctionApr 23, 2025Material Deformation; Material Deformation

  TWO PK PAPYRUS COVERED STENT SYSTEMS WERE CHOSEN FOR THE TREATMENT OF A TYPE III PERFORATION IN THE MAIN BRANCH OF THE LCX, BUT BOTH COULD NOT PASS THE LESION AND GOT DAMAGED. STENT STRUTS WERE STICKING UP. THE PHYSICIAN RATED THIS EVENT AS NEITHER DEVICE NOR PROCEDURE RELATED. THIS IS 2 OF 2. THE DEVICE WAS USED AFTER UBD. THE FIRST PK PAPYRUS IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892708 ↗
• MalfunctionFeb 25, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. INITIALLY THE DEVICE WOULD NOT CROSS BECAUSE OF GUIDE CATHETER SUPPORT. UPON REMOVAL OF THE UNDEPLOYED STENT, IT WAS OBSERVED THAT THE STENT WAS NO LONGER ON THE BALLOON CATHETER. EVERYTHING WAS REMOVED AND A NEW GUIDE CATHETER WAS PLACED AND THE THIRD 2.5/15 PAPYRUS WAS SUCCESSFULLY IMPLANTED. THEY WERE IN A RUSH TO COVER THE PERFORATION AND SPENT NO TIME TRYING TO FIND THE UNDEPLOYED STENT. IT IS UNKNOWN IF THE STENT WAS IN THE CATHETER REMOVED OR REMAINS IN THE BODY NOW.

  Patient problems: Insufficient Information

  MAUDE report 21461183 ↗
• MalfunctionFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION IN THE MID LAD. THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND WAS RETRIEVED WITH A SNARE. IT WAS NOT POSSIBLE TO DELIVER AN ADDITIONAL STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355525 ↗
• MalfunctionDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PK PAPYRUS WAS INTENDED TO TREAT A LESION IN THE MID LAD WITH A BALLOON DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. TO STOP THE BLEEDING, BALLOON DILATION WAS PERFORMED. THEREAFTER, THE AFFECTED PK PAPYRUS COVERED STENT SYSTEM WAS INTRODUCED INTO THE PATIENTS BODY BUT THE STENT CAME OFF THE BALLOON BEFORE BEING DEPLOYED. THE AFFECTED DEVICE WAS WITHDRAWN, AND ANOTHER PK PAPYRUS 2.5/15 WAS IMPLANTED TO COVER THE UNDEPLOYED STENT AND SUCCESSFULLY SEAL THE PERFORATION. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20827585 ↗
• MalfunctionAug 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN THE 2ND DIAGONAL OF THE LAD, OCCURRED DURING IMPLANTATION OF A DES. AFTER BALLOON DILATATION TO STOP THE BLEEDING, WHEN THE DEVICE WAS DELIVERED, THE STENT STRIPPED OFF THE BALLOON AND WAS LEFT IN THE DIAGONAL. ANOTHER PK PAPYRUS WAS IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038866 ↗
• MalfunctionJul 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS ATTEMPTED TO DEPLOY A SECOND PK PAPYRUS WHEN THE OUTER POLYURETHANE COVER GOT CAUGHT IN THE GUIDELINER AND STARTED TO SEPARATE FROM THE STENT. THE GUIDELINER WAS PUT IN AFTER DELIVERING THE FIRST PKP AND WAS NOT COMPATIBLE FOR THE CROSSING PROFILE OF THE SECOND DEVICE. BY THAT TIME THE PERFORATION WAS UNDER CONTROL AND THE CASE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822891 ↗
• MalfunctionJul 24, 2024Use of Device Problem; Use of Device Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE FIRST OBTUSE MARGINAL. THE STENT WAS IMPLANTED ON (B)(6) 2024, BUT WAS EXPIRED ON 31-DEC-2023. THE EXPIRED PRODUCT WAS CHOSEN, AS THE SITUATION WAS LIFE THREATENING IF NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822889 ↗
• MalfunctionMay 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION IN THE DISTAL LAD, OCCURRED DURING TREATMENT WITH SEVERAL DES. THE STENT CAUGHT ON LEFT MAIN STENT AND STRIPPED OFF BALLOON. TWO OTHER PK PAPYRUS WERE IMPLANTED AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331568 ↗
• MalfunctionMay 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION OF THE MID RCA AFTER USE OF ATHERECTOMY. PK PAPYRUS WAS INSERTED INTO THE GUIDE, PASSED THROUGH AND IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON WHEN IN THE VESSEL. THE STENT WAS LOCATED IN THE GUIDE CATHETER. TWO OTHER PK PAPYRUS STENTS WERE IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277047 ↗
• MalfunctionFeb 21, 2024Inflation Problem; Activation Failure; Inflation Problem; Activation Failure

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION WHICH OCCURRED DURING BALLOON DILATATION IN THE 2ND DIAGONAL OF THE LAD. THE STENT WAS UNINTENTIONALLY REMOVED ON BALLOON AFTER ATTEMPTED DEPLOYMENT. STENT DID NOT DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18751730 ↗
• DeathNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION IN THE PROXIMAL LAD DUE TO NC BALLOON RUPTURE. FIRST, A BALLOON TAMPONADE WAS PERFORMED AND SUBSEQUENTLY, THE PK PAPYRUS WAS INTRODUCED. THE STENT SLID OFF THE BALLOON. ANOTHER PK PAPYRUS WAS IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED. LATER, THROMBUS FORMATION NOTED IN THE LCX ARTERY WHICH WAS MANAGED WITH ASPIRATION THROMBECTOMY AND A DES PLACEMENT. PATIENT WAS ADMITTED TO THE ICU. POST PROCEDURE, PATIENT PASSED AWAY ON SAME DAY DUE TO CARDIOGENIC SHOCK. THE PHYSICIAN RATED THE DEATH AS NOT DEVICE RELATED COMPLICATION.

  Patient problems: Cardiogenic Shock

  MAUDE report 18188713 ↗
• DeathOct 30, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING TREATMENT OF A CORONARY CAMERAL FISTULA A DYE EXTRAVASATION WAS NOTED ON FLUORO AS CONSEQUENCE OF A LATE SEQUELA OF AN INFERIOR MYOCARDIAL INFARCTION. AFTER TREATMENT WITH BALLOON FOR TAMPONADE, THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT, BUT THE STENT STRIPPED OFF THE BALLOON WHILE TRYING TO ADVANCE IT THROUGH THE STENTED SECTION OF THE RCA OR ON REMOVAL AFTER IT COULD NOT CROSS. THE DEVICE WAS RETRIEVED FROM BODY. ANOTHER PK PAPYRUS WAS DEPLOYED SUCCESSFULLY. MILD BLEEDING INTO LV CAVITY LED TO EMERGENT SURGERY FOR ACUTE MITRAL VALVE. TWO DAYS POST-PROCEDURE THE PATIENT PASSED AWAY. PHYSICIAN COMMENTED THAT THE DEATH IS UNRELATED TO THE COMPLAINT EVENT.

  Patient problems: Cardiogenic Shock

  MAUDE report 18030391 ↗
• InjurySep 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION IN THE 1ST DIAGONAL OCCURRED DURING A DES IMPLANTATION. THE STENT WAS DEPLOYED TO ABOUT 2.7MM. THERE WAS AN EDGE DISSECTION AT THE DISTAL EDGE. THE DISSECTION WAS OVER-STENTED WITH A DES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 17711750 ↗
• MalfunctionAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE I PERFORATION IN THE MAIN BRANCH OF THE LCX. TO STOP THE BLEEDING BALLOON DILATION WAS PERFORMED. AFTERWARDS THE COMPLAINT PK PAPYRUS WAS PREPARED, BUT THE STENT CAME OFF THE BALLOON OUTSIDE PATIENT. THEREAFTER, A PK PAPYRUS 2.5/20 WAS INTRODUCED BUT THE LESION COULD NOT BE CROSSED, DESPITE ADDITIONAL PRE-DILATION (REPORTED SEPARATELY). ACCORDING TO THE CATHLAB REPORT, THE DISTAL VESSEL WAS COMPLETELY OCCLUDED AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO PERFORATION DETECTED AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE. NO GRAFTS WERE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572604 ↗