PK Papyrus 3.5/20/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07640130447233), received between May 8, 2019 and Aug 24, 2026 — classified as 13 deaths, 3 injuries, 24 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 40 reports, in the reporter's own words as published by the FDA.

• DeathAug 24, 2026Lack of Effect

  During balloon dilatation of the prox. LCX, an Ellis Type III coronary peroration occurred. Three PK Papyrus coronary covered stents were implanted in an attempt to control the bleeding. Despite the treatment performed, the perforation was reported as not successfully sealed. The patient died during the procedure due to hemorrhage from coronary perforation. The physician stated that this the bleeding might have resulted from concurrent or late micro perforation of the LAD, a small ramus branch, or the LM. The cause of the reported event is currently under investigation. This report pertains to one of three PK Papyrus devices used in the same procedure involving the same patient and clinical event. The other two devices are reported separately under MDR Report 8043892-2006-073004 and 8043892-2006 073005.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50400884 ↗
• MalfunctionApr 30, 2026Device Dislodged or Dislocated

  DURING TREATMENT OF THE RCA, WHEN PERFORMING BALLOON DILATATION WITH AN NC BALLOON, A PERFORATION OCCURRED. IT WAS DECIDED TO USE A PK PAPYRUS COVERED SENT SYSTEM, BUT THE COVERED STENT WAS UNABLE TO BE DELIVERED AND DISLODGED FROM THE BALLOON. ANOTHER PK PAPYRUS STENT WAS SUCCESSFULLY DEPLOYED AND RESOLVED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25039976 ↗
• DeathOct 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID RCA. THE AFFECTED DEVICE WAS INTRODUCED BUT THE STENT DISLODGED OFF BALLOON AND MIGRATED DISTALLY. TWO PK PAPYRUS STENTS WERE IMPLANTED AFTERWARDS. PATIENT EXPERIENCED CARDIOGENIC SHOCK AND DESPITE RESUSCITATION HE PASSED AWAY. IT WAS STATED BY THE PHYSICIAN THAT THE DEATH IS NOT RELATED TO THE COMPLAINT DEVICE.

  Patient problems: Cardiac Tamponade; Shock

  MAUDE report 20476618 ↗
• MalfunctionApr 15, 2024Failure to Advance; Failure to Advance

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. SINCE THE LESION COULD NOT BE CROSSED WITH THE DEVICE, THE DEVICE WAS UNABLE TO SEAL THE PERFORATION AND WAS NOT DEPLOYED. PATIENT MOVED EMERGENTLY TO OR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110847 ↗
• MalfunctionNov 14, 2023Fracture; Fracture

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE POSTERIOR TIBIAL ARTERY. THIS OCCURRED DURING REVASCULARIZATION OF THE SFA WHEN REMOVING ALL INSTRUMENTS. THE DEVICE BROKE ALONG THE SHAFT UPON INSERTION. A SECOND PK PAPYRUS WAS USED, AND PERFORATION WAS SEALED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133823 ↗
• MalfunctionOct 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING TREATMENT OF A SVG-OM3 WITH A DES, A PERFORATION OCCURRED. THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED BUT THE STENT CAME OFF BALLOON INSIDE A 6F GUIDELINER. ANOTHER PK PAPYRUS WAS SUCCESSFULLY PLACED AND SEALED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012064 ↗
• InjuryJul 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A TYPE III CS/IV CORONARY ARTERY PERFORATION IN THE 1ST DIAGONAL ARTERY. THE DECISION WAS MADE TO IMPLANT THE COMPLAINT STENT ACROSS THE BIFURCATION TO THE 1ST DIAGONAL. THE COMPLAINT INSTRUMENT WAS INTRODUCED INTO THE PATIENTS BODY, BUT THE STENT DISPLACED FROM THE BALLOON UNNOTICED IN PROXIMAL DIRECTION. THE STENT WAS DEPLOYED WITH 18 ATM. AFTER DEFLATING THE BALLOON, RESISTANCE WAS FELT DURING WITHDRAWAL. A STENT BOOST WAS PERFORMED, AND IT WAS REALIZED THAT THE STENT HAS ONLY EXPANDED IN ITS DISTAL PORTION AND WAS STILL UNEXPANDED IN ITS PROXIMAL PORTION. THE STENT ITSELF, WAS NOT COVERING THE BIFURCATION TO THE 1ST DIAGONAL. THE MISPLACED STENT WAS POST-DILATED WITH TWO DIFFERENT BALLOONS IN ITS PROXIMAL SECTION. A SECOND PK PAPYRUS 2.5/15 (REPORTED SEPARATELY UNDER MDR NUMBER 1028232-2023-02507) WAS CHOSEN TO BE IMPLANTED OVER THE BIFURCATION TO THE 1ST DIAGONAL AS A REPLACEMENT. THE PK PAPYRUS 2.5/15 WAS INTRODUCED USING A 6F EBU4 GUIDING CATHETER BUT DISLODGED INSIDE THE CATHETER DURING THE ADVANCEMENT. THE BALLOON OF THE DELIVERY SYSTEM WAS INFLATED DISTAL TO THE DISLODGED STENT TO PREVENT THE STENT FROM EXITI

  Patient problems: Insufficient Information

  MAUDE report 17406757 ↗
• MalfunctionJul 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A SEVERELY CALCIFIED LESION IN THE LAD WAS TREATED WITH ROTATIONAL ATHERECTOMY AND PRE-STENT ANGIOPLASTY WITH MULTIPLE BALLOONS, FOLLOWED BY STENTING WITH 3 DES IN OVERLAPPING MANNER. A TYPE II PERFORATION OCCURRED BUT THEN PROGRESSED TO A TYPE III PERFORATION. THREE PK PAPYRUS STENTS WERE IMPLANTED BUT IN THE MIDDLE STENT (3.5/20) A LEAK/TEAR WAS NOTICED. AN ADDITIONAL PK PAPYRUS WAS IMPLANTED WHICH RESULTED IN A COMPLETE SEALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17325651 ↗
• DeathMay 17, 2023Failure to Advance; Failure to Advance

  PK PAPYRUS COVERED STENTS WERE SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN A SIDE BRANCH OF THE LCX OCCURRED DURING ROTABLATION. THE 1ST PK PAPYRUS( 2.5/20) COULD NOT BE DELIVERED, AND AFTER REMOVAL THE STENT FELL ON THE FLOOR. THE 2ND PK PAPYRUS (2.5/20) COULD ALSO NOT BE DELIVERED, AND THE STENT CAME OFF THE BALLOON. THE 3RD STENT (3.5/20) WAS BIGGER AND COULD NOT BE DELIVERED AS WELL. THE PERFORATION WAS SEALED WITH BALLOON TAMPONADE ONLY. WHILE TRYING TO DELIVER THE PK PAPYRUS STENTS, A DISSECTION OF THE LEFT MAIN HAD OCCURRED WHICH LED TO PATIENTS DEATH DURING THE PROCEDURE. ALL AFFECTED DEVICES ARE SUBMITTED SEPARATELY. THIS REPORT REFERS TO THE 3RD STENT.

  Patient problems: Vascular Dissection

  MAUDE report 16946623 ↗
• 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 16934975 ↗
• MalfunctionMay 5, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN A VENOUS GRAFT. THE STENT COULD NOT SEAL THE PERFORATION PROPERLY. A 2ND PKP WAS SUCCESSFULLY IMPLANTED AND SEALED THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876762 ↗
• DeathApr 12, 2023Lack of Effect; Lack of Effect

  DURING AN INTERVENTION WITH A ROTABLATOR, A PERFORATION HAD OCCURRED IN THE RCA. THE PK PAPYRUS 3.5/20 WAS IMPLANTED BUT DID NOT SEAL COMPLETELY (COMPLAINT EVENT). ANOTHER PK PAPYRUS (4.5/20) WAS USED, BUT DURING THE ATTEMPT TO DEPLOY THE STENT, IT DISLODGED FROM THE BALLOON (REPORTED SEPARATELY). THE DELIVERY SYSTEM WAS USED TO DEPLOY THE STENT PARTIALLY. THE POST-DILATATION AND FULL EXPANSION WAS PERFORMED WITH A NC BALLOON. A THIRD PK PAPYRUS STENT WAS IMPLANTED, AND THE PERFORATION WAS SUCCESSFULLY SEALED. PATIENT EXPIRED THE FOLLOWING DAY DUE TO CARDIOGENIC SHOCK, NOT RELATED TO THE PK PAPYRUS EVENTS.

  Patient problems: Cardiogenic Shock

  MAUDE report 16724980 ↗
• MalfunctionMar 30, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT WAS PLACED FOR SEALING A PERFORATION IN THE MID RCA. DURING POST DILATATION IT WAS RECOGNIZED THAT ANOTHER PERFORATION HAD OCCURRED MORE PROXIMAL. THIS OTHER PROXIMAL PERFORATION WAS TREATED WITH A PK PAPYRUS 3.5/20 STENT, BUT IT DID NOT SEAL. THEREFORE, A SECOND PK PAPYRUS 3.5/20 STENT WAS IMPLANTED, WHICH SUCCESSFULLY SEALED THE PROXIMAL PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645931 ↗
• DeathMar 16, 2023Lack of Effect; Lack of Effect

  THIS WAS A VERY HIGH-RISK PCI WITH A TYPE II PERFORATION IN THE LEFT MAIN AFTER CSI ATHERECTOMY. THE BLEEDING WAS NOT RESOLVE AFTER BALLOON INFLATION AND STENTING. THE PK PAPYRUS COVERED STENT WAS PLACED, BUT THERE WAS PERSISTENT EFFUSION DISTAL TO THE STENT. PERICARDIOCENTESIS WAS PERFORMED. PATIENT DEVELOPED CARDIAC ARREST AND REQUIRED MULTIPLE ROUNDS OF CPR. PATIENT WAS INTUBATED AND A PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY TEMPORARY PACEMAKER PLACEMENT. PATIENT CONTINUED TO SPIRAL DOWN INTO CARDIOGENIC SHOCK. FURTHER MULTIPLE ROUNDS OF CPR FOR OVER ONE HOUR WERE PERFORMED. AFTER ADDITIONAL PROLONGED BALLOON INFLATION AND IMPLANTATION OF ANOTHER PK PAPYRUS STENT, THE BLEEDING WAS STOPPED, BUT PATIENT WAS IN CARDIAC STANDSTILL.

  Patient problems: Cardiac Arrest; Cardiogenic Shock

  MAUDE report 16553021 ↗
• MalfunctionMar 7, 2023Lack of Effect; Lack of Effect

  DURING TREATMENT WITH A SHOCKWAVE BALLOON IN THE MID RCA, A TYPE III PERFORATION HAD OCCURRED. THE PK PAPYRUS COVERED STENT WAS SUCCESSFULLY DELIVERED BUT FAILED TO SEAL THE PERFORATION. A SECOND PKP WAS PLACED OVERLAPPING THIS STENT AND WAS SUCCESSFUL TO SEAL THE PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497463 ↗
• DeathFeb 13, 2023Lack of Effect; Lack of Effect

  DURING STENTING OF A SEVERELY CALCIFIED LESION WITH 99 PERCENT STENOSIS DEGREE IN THE MID RCA, A TYPE III PERFORATION OCCURRED IN THE PROXIMAL RCA. AN EMERGENT BYPASS AND LIGATION OF THE PERFORATION WAS DISCUSSED, BUT FIRST CONTROLLING OF THE PERFORATION WITH OTHER METHODS WAS PREFERRED. SUBSEQUENTLY, PK PAPYRUS COVERED STENTS WERE USED TO SEAL THE PERFORATION. THE SEALING COULD BE ACHIEVED WITH IMPLANTING THE THIRD STENT. AFTERWARDS, THE SEVERE STENOSIS DISTALLY WAS TREATED WITH TWO DRUG-ELUTING COMPETITORS STENTS. THE VESSEL WAS FULLY REVASCULARIZED, NO SIGNIFICANT STENOSIS, NO EDGE DISSECTION AND NOT FURTHER EXTRAVASATION OF CONTRAST. AN IMPELLA WAS PLACED DURING THE PROCEDURE. FOLLOWING THE INTERVENTION, THE PATIENT WENT TO BYPASS SURGERY. 16 DAYS AFTER SURGERY PATIENT DIED DUE TO CARDIOGENIC SHOCK. THIS COMPLAINT REFERS TO THE FIRST STENT. THE OTHER TWO STENTS ARE FILED SEPARATELY.

  Patient problems: Cardiogenic Shock

  MAUDE report 16363209 ↗
• MalfunctionJan 5, 2023Lack of Effect; Lack of Effect

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THE COMPLAINT STENT COULD NOT SEAL THE PERFORATION COMPLETELY. AN ADDITIONAL PK PAPYRUS WAS IMPLANTED IN OVERLAPPING MANNER, BUT THE PERFORATION WAS STILL NOT SEALED (REPORTED SEPARATELY). A THIRD PK PAPYRUS WAS IMPLANTED, AND THE PERFORATION WAS THEN SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103766 ↗
• DeathNov 29, 2022Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  A PERFORATION WAS OBSERVED AFTER DEPLOYMENT OF TWO COMPETITORS STENTS. THE PK PAPYRUS COVERED STENT SYSTEM WAS INSERTED. DEPLOYMENT WAS NOT POSSIBLE DUE TO HIGHLY CALCIFIED LESIONS. THE ENTIRE UNIT WAS PULLED OUT, AND STENT CAME OFF THE BALLOON. THE STENT COULD NOT BE RETRIEVED. PATIENT WENT INTO CARDIOPULMONARY ARREST AS A RESULT OF THE PERFORATION AND CARDIOGENIC SHOCK.

  Patient problems: Cardiac Arrest; Cardiogenic Shock

  MAUDE report 15880632 ↗
• MalfunctionNov 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THE PK PAPYRUS COVERED STENT FELL OFF THE BALLOON PRE-DEPLOYMENT IN THE PREPARATION PHASE. THE DEVICE WAS NOT INTRODUCED INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798361 ↗
• InjuryOct 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS USED TO TREAT A TYPE III CS/IV PERFORATION IN THE MID LAD. WHEN STENT WAS PLACED A NEW PERFORATION OCCURRED AT THE PROXIMAL MARGIN OF THE PK PAPYRUS STENT. A 2ND PK PAPYRUS STENT WAS IMPLANTED TO SEAL THE NEW PERFORATION AND TO GET MORE EFFECTIVE SEALING OF THE FIRST ONE.

  Patient problems: Perforation of Vessels

  MAUDE report 15663849 ↗
• DeathOct 12, 2022Lack of Effect

  AFTER PERFORMING A PCI OF THE LAD AND DEPLOYING A DRUG-ELUTING STENT SYSTEM, A LARGE PERFORATION IN THE DISTAL SEGMENT WITH ACTIVE EXTRAVASATION INTO THE PERICARDIUM WAS DETECTED. THUS, A PK PAPYRUS STENT SYSTEM WAS PLACED WHICH COULD NOT COMPLETELY STOP THE BLEEDING. THE PATIENT WAS QUICKLY IN CARDIAC TAMPONADE AND WHILE PREPARING FOR PERICARDIOCENTESIS, THE STENTED SEGMENTS THROMBOSED WITH CLOT EXTENDING TOWARDS THE LEFT MAIN. ASPIRATION THROMBECTOMY WAS PERFORMED AND ADDITIONAL VESSEL RUPTURES WERE NOTED WHICH WERE TREATED WITH THREE MORE PK PAPYRUS STENT SYSTEMS. THERE WAS STILL A BIT OF MICRO BLUSH IN THE PROXIMAL SEGMENT OF THE LAD AND BECAUSE OF THE USE OF THE PKPS, MULTIPLE SIDE BRANCHES INCLUDING THE SEPTALS WERE JAILED OFF. THE PATIENT DIED 3 DAYS LATER WHICH WAS NOT DEVICE RELATED. THIS IS FOUR OF FOUR REPORTS. (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 15588218 ↗
• 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 TWO OF FOUR. DEVICE CODE IS 4065.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587299 ↗
• DeathAug 16, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UPON BALLOON ANGIOPLASTY, IN PREPARATION TO PROCEED WITH POSSIBLE STENT PLACEMENT, THE PATIENT HAD A TYPE III CS/IV PERFORATION IN THE PROXIMAL LCX, WHICH COULD NOT BE SUCCESSFULLY SEALED WITH TWO PK PAPYRUS COVERED STENTS (THE SECOND STENT IS REPORTED SEPARATELY). EVENTUALLY, THE PATIENT NEEDED A CT SURGERY WITH AN EMERGENT STERNOTOMY BUT THE PATIENT PASSED AWAY BUT AS STATED BY THE HOSPITAL, UNRELATED TO THE DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 15233843 ↗
• MalfunctionAug 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING TREATMENT OF A TYPE III CS/IV PERFORATION, THE FIRST PK PAPYRUS (5.0/15) WAS PLACED BUT THE STENT DISLODGED. (SEE MEDWATCH 1028232-2022-03613.) THE COMPLAINT DEVICE (3.5/20) COULD NOT PASS THE LESION WAS WITHDRAWN AND REINSERTED BUT COULD NOT CROSS AGAIN. DURING WITHDRAWAL THE STENT DISLODGED. THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND WAS THEREFORE TRANSFERRED TO OPERATING ROOM. AN EMERGENT STERNOTOMY WAS PERFORMED. AN APPROX. 0.5 INCH TEAR WAS NOTICED AT THE RV-RA JUNCTION. PATIENT HAD SVG TO PDA AND DIRECT REPAIR OF THE RCA TO RV TEAR.

  Patient problems: Pericardial Effusion

  MAUDE report 15224664 ↗
• MalfunctionAug 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS ATTEMPTED TO TREAT AN ISR OF THE PROXIMAL LAD. MULTIPLE PASSES WITH ROTAPRO DUE TO CALCIFICATION, WHICH LED TO TYPE III PERFORATION OF PROXIMAL LAD. AFTER BALLOON DILATATION, IT WAS TRIED TO ADVANCE THE PK PAPYRUS COVERED STENT SYSTEM THROUGH THE GUIDING CATHETER. THE STENT DISLODGED OFF THE DELIVERY SYSTEM, BUT IT WAS POSSIBLE TO RETRIEVE IT FROM INSIDE THE GUIDING CATHETER. THIS OCCURRED ALSO WITH 2 OTHER PK PAPYRUS STENTS (REPORTED SEPARATELY.) NO PART OF THE STENT REMAINED IN THE PATIENT. 3 OTHER PK PAPYRUS WERE SUCCESSFULLY DEPLOYED INTO PROXIMAL LAD AND LEFT MAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15217141 ↗