PK Papyrus 3.5/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07640130447288), received between Mar 20, 2020 and Jul 11, 2023 — classified as 4 deaths, 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE PROXIMAL RCA. THE STENT CAME OFF BALLOON INSIDE PATIENT AND WAS NOT DEPLOYED. THE STENT WAS PINNED BY ANOTHER STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 5 DAYS AFTER PROCEDURE THE PATIENT BECAME HEMODYNAMIC INSTABLE, NEEDED RESUSCITATION, AND DIED IN HOSPITAL. FURTHER CLARIFICATIONS ARE ONGOING.

  Patient problems: Cardiac Arrest

  MAUDE report 17298486 ↗
• MalfunctionMay 17, 2023Lack of Effect; Lack of Effect

  THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID LAD. THE STENT DID NOT SEAL THE PERFORATION. ANOTHER PK PAPYRUS STENT WAS IMPLANTED IN OVERLAPPING MANNER, AND THE PERFORATION WAS SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946405 ↗
• MalfunctionMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THREE PK PAPYRUS COVERED STENTS WERE USED FOR TREATMENT OF A TYPE III PERFORATION IN THE LCX. STENTS #1 AND #2 PARTIALLY STRIPPED OFF OF BALLOON BUT WERE ABLE TO BE REMOVED. STENT #3 STRIPPED OFF OF THE BALLOON IN THE CORONARY ARTERY. IT WAS ULTIMATELY RETRIEVED VIA SNARE AND REMOVED, INTACT, FROM THE BODY. THE PERFORATION SEALED SPONTANEOUSLY WITH BALLOON TAMPONADE ALONE. IT IS UNSURE WHICH LOT NUMBERS RELATES TO WHICH STENT. THE OTHER STENTS WERE REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906629 ↗
• 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 THIRD STENT. THE OTHER TWO STENTS ARE REPORTED SEPARATELY.

  Patient problems: Cardiogenic Shock

  MAUDE report 16363211 ↗
• MalfunctionJan 5, 2023Lack of Effect; Lack of Effect

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103771 ↗
• MalfunctionDec 7, 2022Failure to Advance; Failure to Advance

  DURING TREATMENT OF A TYPE III PERFORATION IN THE RCA, THE PK PAPYRUS COVERED STENT SYSTEM COULD NOT PASS THE PRE-DILATED SEVERELY CALCIFIED LESION AND WAS WITHDRAWN. THE INTERVENTION WAS COMPLETED WITH ANOTHER PK PAPYRUS, AND THE PERFORATION WAS SUCCESSFULLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931440 ↗
• 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 THREE OF FOUR REPORTS. DEVICE CODE IS (B)(4).

  Patient problems: Perforation of Vessels

  MAUDE report 15588222 ↗
• 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 15217126 ↗
• InjurySep 8, 2021Failure 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 LAD. POST ROTABLATION, A BALLOON RUPTURE WAS CAUSING THE PERFORATION. FIRST, A BALLOON DILATATION WAS PERFORMED TO STOP THE BLEEDING. SUBSEQUENTLY, THE PKP WAS USED BUT DESPITE USING A 7F GUIDELINER THE DEVICE WAS UNABLE TO BE ADVANCED. THE DEVICE WAS RETRIEVED. AFTER REMOVAL, IT WAS DETECTED THAT THE STENT WAS HALF WAY OFF THE BALLOON. ANOTHER PK PAPYRUS WAS USED. IT WAS REPORTED THAT EIGHT DAYS POST PROCEDURE THE PATIENT PASSED AWAY, BUT THE DEATH WAS NOT RELATED TO THE PK PAPYRUS.

  Patient problems: Failure of Implant

  MAUDE report 12438704 ↗
• MalfunctionMay 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION IN THE RCA. DURING PRE-DILATATION OF THE LESION SEVERAL BALLOONS RUPTURED BUT A DRUG ELUTING STENT COULD BE SUBSEQUENTLY IMPLANTED. DURING POST-DILATATION THE PERFORATION WAS DETECTED. THE PERFORATION WAS TAMPONADE WITH A BALLOON FOR 5 MIN. SUBSEQUENTLY, THE PK PAPYRUS WAS DELIVERED BUT DID NOT ADVANCE ACROSS THE PERFORATED SEGMENT, STRIPPED OF THE BALLOON AND WAS DEPLOYED PROXIMAL TO THE PERFORATION. ANOTHER PK PAPYRUS WAS IMPLANTED AND THE PERFORATION WAS SEALED. PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11856228 ↗
• DeathMay 20, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A PK PAPYRUS COVERED STENT SYSTEM (3.5X26 MM) WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION LOCATED AT THE PROX. LAD. A SEVERELY CALCIFIED LESION IN THE PROXIMAL LAD WAS BALLOONED AND SUBSEQUENTLY TREATED WITH A ROTABLATOR DUE TO THE HEAVY CALCIUM BURDEN (VESSEL REFERENCE DIAMETER 3.75 MM; STENOSIS DEGREE 90 PERCENT, LESION LENGTH 20 MM) . ACCORDING TO THE PHYSICIAN THE PERFORATION WAS CAUSED AS A RESULT OF THE ROTABLATOR TREATMENT. STANDARD ROTABLATOR EQUIPMENT, INCLUDING THE ROTAWIRE AND ROTABLATOR BURR WERE USED ALONG WITH AN EBU GUIDECATHETER. IN ORDER TO STOP THE BLEEDING PROTAMINE INJECTION AND BALLOON DILATATION WAS PERFORMED PRIOR TO THE USE OF THE PK PAPYRUS COVERED STENT. THE PK PAPYRUS COVERED STENT WAS SUCCESSFULLY PLACED IN THE TARGET LESION (PROX. LAD) AND THE PERFORATION WAS SUCCESSFULLY SEALED (APPLIED PRESSURE 14 ATM/45 SEC; NO POST DILATATION WAS PERFORMED). PER PHYSICIAN COMPLICATION WAS STENT THROMBOSIS FOLLOWING COVERED STENT DEPLOYMENT, DISTAL TO THE STENT. PATIENT EXPERIENCED CARDIOGENIC SHOCK AND PASSED AWAY ON THE TABLE.

  Patient problems: Cardiogenic Shock; Thrombosis/Thrombus

  MAUDE report 11854482 ↗
• MalfunctionApr 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT DEVELOPED A VESSEL PERFORATION AND A PK PAPYRUS COVERED CORONARY STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. IT WAS NOT POSSIBLE TO DELIVER THE STENT TO THE MID LAD AND WAS THUS REMOVED. DURING WITHDRAWAL THE STENT DISLODGED INSIDE THE PROX. LAD AND IT WAS DECIDED TO INSERT DIFFERENT BALLOON CATHETERS (SIZE 2.0 AND 3.0) TO IMPLANT THE DISLODGED STENT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700591 ↗
• InjuryJul 13, 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-1028232-2020-02867.

  Patient problems: Myocardial Infarction

  MAUDE report 10268191 ↗
• MalfunctionJun 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PK PAPYRUS US COVERED STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A DISSECTION IN THE LAD. UPON GOING THROUGH THE (B)(6) GUIDING CATHETER THE STENT DISLODGED FROM THE BALLOON AND WAS STUCK INSIDE THE LM. EVENTUALLY THE DISLODGED STENT WAS SNARED FROM THE PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135699 ↗
• InjuryMar 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT WAS FOUND IN AN INTERNAL AUDIT. A PK PAPYRUS US COVERED STENT SYSTEM WAS USED TO TREAT A PERFORATION IN THE RCA. PERI-PROCEDURAL, THERE WAS AN ACUTE IN-STENT THROMBOSIS.

  Patient problems: Thrombosis

  MAUDE report 9865119 ↗
• DeathMar 20, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS REPORT WAS FOUND IN AN INTERNAL AUDIT. A PK PAPYRUS COVERED STENT SYSTEM WAS USED TO TREAT A PERFORATION. PERIPROCEDURAL, THERE WAS AN ACUTE IN-STENT THROMBOSIS. PATIENT PASSED AWAY TWO DAYS AFTER INTERVENTION.

  Patient problems: Death; Thrombosis

  MAUDE report 9860026 ↗