PK Papyrus 5.0/20/140Recalls & reported problems
Biotronik AG · Class f · Implant
All models of PK Papyrus (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130447264), received between Aug 20, 2019 and Aug 6, 2024 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Failure to Advance1
Patient problems
- Cardiac Tamponade1
- No Consequences Or Impact To Patient1
- Pericardial Effusion1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
THERE WAS A TYPE III CS/IV PERFORATION IN THE PROX. LAD IN AN UNSTENTED AREA DUE TO A GEOGRAPHIC MISS WHILE OVERLAPPING DES STENTS. THE PK PAPYRUS COVERED STENT SYSTEM WAS INSERTED INTO THE 6F GUIDE CATHETER AND RESISTANCE WAS EXPERIENCED WHILE COMING THROUGH THE GUIDE IN THE SUBCLAVIAN AREA (STILL IN THE GUIDE). THE OPERATOR NOTED THE STENT APPEARED TO START DISLODGING FROM THE STENT DELIVERY SYSTEM. THE STENT, STENT DELIVERY SYSTEM, AND GUIDE CATHETER WERE ALL SUCCESSFULLY REMOVED. THE PATIENTS PERFORATION IMPROVED WITH COMPLETE RESOLUTION OF THE EFFUSION AND WAS SUBSEQUENTLY DISCHARGED TWO DAYS POST OP.
Patient problems: Cardiac Tamponade; Pericardial Effusion
MAUDE report 19917471 ↗MalfunctionAug 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN PK PAPYRUS COVERED STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING ADVANCING THE DEVICE THROUGH A GUIDEZILLA EXTENSION CATHETER THE STENT DISLODGED. THE STENT WAS RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8913037 ↗
Other coronary covered stent devices
- Graftmaster 1012580-16Abbott Vascular Inc. · coronary covered stent39 deaths233 reports
- PK Papyrus 2.5/20/140Biotronik AG · coronary covered stent11 deaths105 reports
- PK Papyrus 2.5/15/140Biotronik AG · coronary covered stent12 deaths96 reports
- Graftmaster 1012582-16Abbott Vascular Inc. · coronary covered stent9 deaths68 reports
- PK Papyrus 3.5/15/140Biotronik AG · coronary covered stent7 deaths41 reports
- PK Papyrus 3.5/20/140Biotronik AG · coronary covered stent13 deaths40 reports
- PK Papyrus 3.0/15/140Biotronik AG · coronary covered stent6 deaths33 reports
- PK Papyrus 3.0/26/140Biotronik AG · coronary covered stent5 deaths25 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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