PK Papyrus 4.5/20/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07640130447257), received between Apr 15, 2021 and Apr 16, 2026 — classified as 4 deaths, 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Device Dislodged or Dislocated

  PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A PSEUDOANEURYSM OF THE HEPATIC ARTERY. PATIENT UNDERWENT A WHIPPLE PROCEDURE WITH A HEPATIC ARTERY BYPASS. A PSEUDOANEURYSM DEVELOPED AT PROXIMAL ANASTOMOSIS. AFTER IMPLANTING A 4.0/26, A 4.5/26 AND A 4.0/20 PK PAPYRUS STENT, REPEAT ANGIOGRAM DEMONSTRATED SOME SEPARATION BETWEEN THE 2 DISTAL STENTS. AT THIS POINT AN ATTEMPT WAS MADE TO INSERT A FOURTH PAPYRUS STENT (COMPLAINT DEVICE) BUT THIS WAS UNSUCCESSFUL. IT WAS DECIDED TO SWITCH TO A STIFFER WIRE, HOWEVER THE STENT CAME OFF THE BALLOON AND GOT CAUGHT AT THE LEVEL OF THE CELIAC ARTERY. TO ENSURE THAT THIS WOULD NOT MIGRATE OVER AN 014 WIRE WE PLACED A 6/15 MM BARE-METAL STENT IN THE CELIAC ARTERY TO TRAP THE DISLODGED STENT. NO ADVERSE CONSEQUENCES AND THE PATIENT DID WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24893425 ↗
• MalfunctionJan 28, 2026Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION OCCURRED DURING ROTABLATION IN THE PROXIMAL RCA. THE DEVICE WAS INTRODUCED, BUT THE STENT STRIPPED OFF THE BALLOON. THE DEVICE WAS SAFELY REMOVED. THE PERFORATION WAS FINALLY SEALED BY USING ANOTHER PK PAPYRUS COVERED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197311 ↗
• MalfunctionJul 29, 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 PK PAPYRUS PARTIALLY STRIPPED OFF THE BALLOON AND A SECOND OVERLAPPING STENT WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856847 ↗
• MalfunctionJul 24, 2024Failure 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 SPONTANEOUS PERFORATION IN THE POSTERIOR TIBIAL ARTERY. IT WAS DIFFICULT ADVANCING THE STENT. WHEN THE STENT WAS REMOVED, IT WAS HALF OFF THE BALLOON. A PKP 4.5/12 WAS ADVANCED AND SUCCESSFULLY DEPLOYED WITH NO ISSUE AND IT WAS SUCCESSFUL IN STOPPING THE BLEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822656 ↗
• InjuryNov 27, 2023Lack of Effect; Lack of Effect

  THE PK PAPYRUS STENT DID NOT SEAL A TYPE I PERFORATION IN THE RCA COMPLETELY BUT SLOWED THE LEAK SIGNIFICANTLY. ACCORDING TO THE INFORMATION FROM THE HOSPITAL, THE PATIENT ALSO EXPERIENCED AN ACUTE THROMBOSIS DURING PROCEDURE AND WAS TRANSFERRED TO A CABG SURGERY, BUT BOTH WERE NOT RELATED TO THE DEVICE AS IT BECAME APPARENT THAT STENTING THE PATIENT MAY NOT HAVE BEEN SAFE FOR THE SEVERE LEFT CORONARY DISEASE, PLUS THE SYNTAX SCORE WAS HIGH. THE PATIENT IS RECOVERING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18211872 ↗
• DeathSep 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III LESION IN THE MID RCA. IT WAS IMPLANTED WITHOUT PROBLEMS, AND THE PERFORATION WAS SUCCESSFULLY SEALED. ON (B)(6) 2023, PATIENT PRESENTED TO ER AFTER AN OUT OF HOSPITAL CARDIAC ARREST. HE WAS TREATED WITH MEDICATION AND WAS MONITORED BUT WAS IN NO CONDITION TO GO TO THE CATH LAB, AND HIS OVERALL PROGNOSIS WAS VERY POOR. PATIENT PASSED AWAY DUE TO CARDIOPULMONARY ARREST AND UNDERLYING STEMI AND ACUTE RENAL FAILURE. AFTER REVIEW OF THE CASE BY A MEDICAL DIRECTOR OF THE HOSPITAL ON (B)(6) 2022, IT WAS STATED THAT IT IS POSSIBLE THAT THE PATIENTS ACUTE INFERIOR MI, LEADING TO PATIENTS DEMISE, MAY BE DUE TO STENT THROMBOSIS INVOLVING THE PK PAPYRUS COVERED STENT. ON (B)(6) 2023 A FOLLOW-UP REGISTRATION FORM WAS FILED, INFORMING ABOUT THE DEATH AND THE POSSIBLE INVOLVEMENT OF THE PK PAPYRUS STENT THROMBOSIS. UPON STUDY HANDOFF TO NEW RESEARCH COORDINATOR, PRINTED EMAIL CORRESPONDENCE REGARDING THIS CASE WAS DISCOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 17777666 ↗
• MalfunctionAug 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS INTENDED TO TREAT A LESION IN THE MAIN BRANCH OF AN SVG DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED. PERFORATION MECHANISM: DES IMPLANTATION. TO STOP THE BLEEDING BALLOON DILATION WAS PERFORMED BUT WERE UNSUCCESSFUL. THEREAFTER, THE COMPLAINT INSTRUMENT WAS INTRODUCED INTO THE PATIENTS BODY, BUT THE STENT DISLODGED FROM THE BALLOON PRIOR TO REACHING THE TARGET LESION AND COULD NOT BE DEPLOYED. THE STENT WAS IMPLANTED WHERE IT HAS DISLODGED. AN ADDITIONAL PK PAPYRUS STENT WAS IMPLANTED TO SEAL THE PERFORATION SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638701 ↗
• DeathApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 (REPORTED SEPARATELY). ANOTHER PK PAPYRUS (4.5/20) WAS USED, BUT DURING THE ATTEMPT TO DEPLOY THE STENT, IT DISLODGED FROM THE BALLOON (COMPLAINT EVENT). 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 16724988 ↗
• 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 FOUR OF FOUR. DEVICE CODE IS 4065.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587289 ↗
• MalfunctionJul 29, 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 MID RCA. THE STENT STRIPPED OFF CATHETER AFTER REMOVAL FROM PACKAGE. IT DID NOT GO IN THE PATIENTS BODY. ANOTHER PK PAPYRUS WAS USED AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129272 ↗
• InjuryJul 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID RCA. THERE WAS STENT THROMBOSIS FOLLOWING THE DEPLOYMENT OF THE STENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15129239 ↗
• MalfunctionJul 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT DISLODGED FROM THE BALLOON AFTER THE PACKAGING WAS OPENED AND THE STYLET REMOVED. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089786 ↗
• DeathMay 12, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE LAD. AFTER DEPLOYMENT OF THE COVERED STENT SIZE 4.5/20 LOSS FLOW IN THE DOMINANT LEFT CX OCCURRED, WHICH REQUIRED ANGIOPLASTY TO RESTORE THE FLOW. A SECOND PERFORATION WAS NOTICED IN THE MID LAD DISTALLY, WHICH WAS COVERED WITH A PK PAPYRUS STENT SIZE 2.5/20. AT THE EDGE OF THIS PK PAPYRUS STENT THERE WAS A DISTAL DISSECTION WHICH WAS TREATED WITH A DES STENT. (THIS EVENT IS REPORTED SEPARATELY.) DESPITE ALL EFFORTS THE PATIENT CONTINUED TO DETERIORATE. PATIENT HAD MULTIPLE COMORBIDITIES AND THE LIKELIHOOD OF MEANINGFUL SURVIVAL WAS LOW TO NONE. PATIENT PASSED AWAY SHORTLY AFTER THE INTERVENTION.

  Patient problems: Cardiac Arrest

  MAUDE report 14380220 ↗
• MalfunctionMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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. THE STENT DISLODGED FROM THE DELIVERY SYSTEM OUTSIDE OF THE PATIENTS BODY AND WAS LATER FOUND ON THE OPERATION TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13726698 ↗
• MalfunctionJan 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING TREATMENT OF A TYPE I PERFORATION IN A SVG, THE STENT CAME OFF OF DELIVERY BALLOON. THE STENT WAS DEPLOYED 2-3MM LOWER THAN THE INTENDED DISTAL TARGET. THE PERFORATION IMPROVED WITH FURTHER BALLOON DILATATION, SO NO ADDITIONAL STENT WAS ATTEMPTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342282 ↗
• DeathDec 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING TREATMENT OF 70 PERCENT STENOSIS IN THE MILDLY TORTUOUS MID RCA WITH A STENT, IT WAS DISCOVERED THROUGH ANGIOGRAPHY THAT A LARGE TYPE III PERFORATION WAS PRESENT. THE PK PAPYRUS COVERED STENT SYSTEM WAS ATTEMPTED TO DELIVER BUT THE STENT DISLODGED FROM BALLOON PROXIMAL TO THE PERFORATION AND WAS DEPLOYED IN THE DISLODGED AREA. THE BALLOON WAS USED TO TAMPONADE THE LESION. PATIENT DEVELOPED HEART BLOCK AND A TEMPORARY PACER WAS IMPLANTED. AT THE END OF THE PROCEDURE, THE PATIENT WAS CRITICAL BUT STABILIZED AND TRANSFERRED TO CVICU. DUE TO POOR PROGNOSIS, PATIENT WAS MADE COMFORT CARE BY FAMILY AND EXPIRED (B)(6) 2021 19:45.

  Patient problems: Heart Block

  MAUDE report 12953731 ↗
• MalfunctionSep 15, 2021Failure to Deliver; Device Dislodged or Dislocated; Failure to Deliver; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MAIN BRANCH OF THE RCA. THE DEVICE GOT STUCK ON SHAFT OF DELIVERY CATHETER. THE DEVICE WAS REMOVED FROM PATIENTS BODY. ANOTHER PK PAPYRUS WAS IMPLANTED AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474121 ↗
• MalfunctionMay 21, 2021Use of Device Problem; Use of Device Problem

  THE PK PAPYRUS WAS IMPLANTED SUCCESSFULLY IN THE SVG WITH NO COMPLAINTS. THE DAY AFTER IMPLANTATION, IT WAS DETECTED THAT THE DEVICE HAD EXPIRED 3 MONTHS AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863033 ↗
• MalfunctionApr 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN CORONARY ANEURYSM. THE STENT STRIPPED OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672064 ↗