PK Papyrus 4.0/26/140Recalls & 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
- 7
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130447295), received between Mar 10, 2022 and Oct 30, 2025 — classified as 1 death, 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Lack of Effect” (3 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
- Lack of Effect3
- Fracture1
- Inflation Problem1
- Malposition of Device1
- Material Deformation1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
- Multiple Organ Dysfunction Syndrome1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
DeathOct 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
AFTER PLACING THE PK PAPYRUS COVERED STENT SYSTEM IN THE MID RCA, THERE WAS A "HAZINESS" IN THE DISTAL STENT WITH ST ELEVATIONS BUT IVUS INTERESTINGLY DID NOT SHOW CLEAR EVIDENCE OF THROMBUS. HOWEVER, WITHIN A FEW MINUTES THE VESSEL SHUT DOWN. AFTER BALLOONING IT WAS POSSIBLE TO RESTORE FLOW, BUT AGAIN, THE VESSEL SHUT DOWN AND APPEARED TO SHOW THROMBUS. IT MAY HAVE ALL BEEN RV FAILURE WITH NO REFLOW. THE PATIENT WAS TRANSFERRED TO ICU AND EXPIRED TWO DAYS AFTER PROCEDURE FROM MULTIORGAN FAILURE. THE DEVICE WAS USED AFTER THE EXPIRATION DATE.
Patient problems: Multiple Organ Dysfunction Syndrome
MAUDE report 23424262 ↗InjuryMay 1, 2023Lack of Effect; Lack of Effect
THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III CS/IV PERFORATION IN THE MID RCA. INITIAL RESULTS LOOKED GOOD WITH TIMI FLOW 3. HOWEVER, OVER TIME POST-PROCEDURE IT APPEARED THAT THE VESSEL WAS DRAINING INTO THE RIGHT ATRIUM. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE HOSPITALIZATION WAS PROLONGED 2 DAYS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16848112 ↗MalfunctionApr 17, 2023Lack of Effect; Lack of Effect
A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE III PERFORATION IN THE MID RCA. THE STENT COULD NOT SEAL THE PERFORATION. THUS, ANOTHER PK PAPYRUS WAS USED, AND SEALED THE PERFORATION SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755819 ↗MalfunctionMar 7, 2023Lack of Effect; Lack of Effect
TWO PK PAPYRUS COVERED STENTS WERE USED TO TRY TO SEAL A TYPE III PERFORATION IN THE PROXIMAL LAD, BUT WERE UNSUCCESSFUL. THE OTHER STENT IS FILED SEPARATELY.
Patient problems: Insufficient Information
MAUDE report 16497462 ↗MalfunctionJan 5, 2023Inflation Problem; Material Deformation; Inflation Problem; Material Deformation
A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT. THE INFLATION LUMEN OF THE DEVICE WAS FOUND KINKED AFTER UNPACKING. HOWEVER, THE DEVICE WAS INSERTED INTO THE PATIENTS BODY BUT COULD NOT BE INFLATED. ANOTHER PK PAPYRUS WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16103113 ↗MalfunctionMar 10, 2022Malposition of Device; Malposition of Device
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 WAS INADVERTENTLY DEPLOYED INSIDE THE GUIDING CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13726667 ↗MalfunctionMar 10, 2022Fracture; Fracture
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 DURING WITHDRAWAL THE BALLOON SHAFT FRACTURED. THEN THE PK PAPYRUS WAS SELECTED FOR TREATING THE PERFORATION, BUT IT WAS NOT POSSIBLE TO DELIVER THE DEVICE TO THE LESION AND THE SHAFT BROKE AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13726575 ↗
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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