PK Papyrus 5.0/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130447318), received between Mar 29, 2022 and Aug 18, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Use of Device Problem; Use of Device Problem

  A LESION WAS TREATED IN A CALCIFIED SVG WITH A DES DURING WHICH A CORONARY ARTERY PERFORATION TYPE III OCCURRED AT THE OSTIUM OF THE VEIN GRAFT TO 1ST DIAGONAL. THE EXPIRED PK PAPYRUS WAS INTRODUCED INTO THE PATIENTS BODY, AND THE STENT WAS SUCCESSFULLY IMPLANTED. AFTER POST-DILATION, PROTAMINE WAS GIVEN, AND AFTER FIVE MINUTES IT WAS CONFIRMED THAT THE PERFORATION WAS SEALED. BEDSIDE ECHOCARDIOGRAM WAS PERFORMED WITH NO PERICARDIAL EFFUSION AND NO OBVIOUS HEMATOMA NOTED ON THE RV FREE WALL. THE PATIENT WAS DISCHARGED THE NEXT DAY. IT WAS NOT REPORTED WHEN IT WAS DISCOVERED THAT THE COMPLAINT STENT HAD BEEN IMPLANTED AFTER ITS EXPIRY DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571984 ↗
• MalfunctionJul 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT IN A RECENT RIGHT KIDNEY TRANSPLANT. BOTH RIGHT RENAL ARTERIES HAD THROMBUS. THE SUPERIOR BRANCH ARTERY WAS VERY TORTUOUS AND WHILE ADVANCING THE STENT IT WAS FORCED OFF THE DELIVERY BALLOON. THE STENT WAS SNARED AND SUCCESSFULLY REMOVED FROM THE PATIENT. A DES WAS PLACED IN THE SUPERIOR BRANCH. A 4.5/26 PKP WAS PLACED IN THE INFERIOR BRANCH SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334085 ↗
• MalfunctionMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING TREATMENT OF AN ANEURYSM, IT WAS NOTICED THAT THE PK PAPYRUS STENT BECAME DISLODGED IN THE GUIDE CATHETER AND WAS RECOVERED. THE PROCEDURE WAS STOPPED DUE TO HAVING NO ADDITIONAL 5.0/26 PKP STENTS. PATIENT WAS DISCHARGED AND THE PROCEDURE WAS RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943866 ↗