PK PapyrusRecalls & reported problems across all models
Biotronik AG · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 466
- Deaths reported
- 84
- Injuries reported
- 62
- Recalls
- 0
We found 17 models of PK Papyrus by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 466 adverse event reports in the FDA's MAUDE database, received between May 8, 2019 and Sep 9, 2026 — classified as 84 deaths, 62 injuries, 320 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (249 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PK Papyrus problems
Device problems
- Device Dislodged or Dislocated249
- Failure to Advance66
- Lack of Effect58
- Patient Device Interaction Problem34
- Material Deformation24
- Positioning Problem16
- Use of Device Problem10
- Material Split, Cut or Torn9
Patient problems
- No Clinical Signs, Symptoms or Conditions258
- No Consequences Or Impact To Patient32
- Cardiogenic Shock30
- Insufficient Information26
- Cardiac Tamponade21
- Failure of Implant20
- Cardiac Arrest14
- Thrombosis/Thrombus12
PK Papyrus models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PK Papyrus 2.5/20/140coronary covered stent11 deaths105 reports
- PK Papyrus 2.5/15/140coronary covered stent12 deaths96 reports
- PK Papyrus 3.5/15/140coronary covered stent7 deaths41 reports
- PK Papyrus 3.5/20/140coronary covered stent13 deaths40 reports
- PK Papyrus 3.0/15/140coronary covered stent6 deaths33 reports
- PK Papyrus 3.0/26/140coronary covered stent5 deaths25 reports
- PK Papyrus 3.0/20/140coronary covered stent9 deaths22 reports
- PK Papyrus 4.0/20/140coronary covered stent5 deaths20 reports
- PK Papyrus 4.5/20/140coronary covered stent4 deaths19 reports
- PK Papyrus 3.5/26/140coronary covered stent4 deaths16 reports
- PK Papyrus 4.0/15/140coronary covered stent2 deaths13 reports
- PK Papyrus 4.5/15/140coronary covered stent2 deaths10 reports
- PK Papyrus 4.5/26/140coronary covered stent2 deaths9 reports
- PK Papyrus 4.0/26/140coronary covered stent1 death7 reports
- PK Papyrus 5.0/15/140coronary covered stent1 death5 reports
- PK Papyrus 5.0/26/140coronary covered stent3 reports
- PK Papyrus 5.0/20/140coronary covered stent2 reports
Recent PK Papyrus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Device Dislodged or Dislocated
The PK Papyrus covered stent was selected for treatment of a type III perforation in the proximal LCx. After balloon dilatation was performed to stop the bleeding, an attempt was made to advance the PK Papyrus to the lesion, but even after several attempts, it was not possible to pass the lesion. When removing the device, it was noticed that there was no outer coating on the stent anymore. The perforation was successfully sealed using another PK Papyrus.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50685923 ↗MalfunctionAug 31, 2026Material Deformation
The PK Papyrus covered stent system was selected for treatment of an injury occurred during a surgical procedure of the right ICA. The stent was damaged when introduced into hemostasis valve. Another PK Papyrus was successfully used.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515350 ↗DeathAug 28, 2026Patient Device Interaction Problem
The patient had severe underlying cardiovascular disease, including multivessel coronary artery disease and reduced left ventricular function. During PCI of the mid to distal LAD, a Type III coronary perforation was reported after DES placement. The perforation was treated with two PK Papyrus covered stents and was reported to have been successfully sealed. During the same procedure, acute thrombosis/occlusion of both PK Papyrus stents was reported, resulting in no-reflow and ventricular tachycardia/cardiac arrest. Following further intervention, final angiography reportedly showed TIMI 3 flow. The patient subsequently developed refractory shock and died later the same day. The cause of the acute stent thrombosis/occlusion and its potential contribution to the patient's death are under investigation. This report pertains to one of two PK Papyrus devices used during the same procedure involving the same patient and clinical event. Since it could not be determined if only one or both PKPs occluded, the second device is reported separately under manufacturer report number 8043892-2026-08114.
Patient problems: Thrombosis/Thrombus
MAUDE report 50492893 ↗DeathAug 28, 2026Patient Device Interaction Problem
The patient had severe underlying cardiovascular disease, including multivessel coronary artery disease and reduced left ventricular function. During PCI of the mid to distal LAD, a Type III coronary perforation was reported after DES placement. The perforation was treated with two PK Papyrus covered stents and was reported to have been successfully sealed. During the same procedure, acute thrombosis/occlusion of both PK Papyrus stents was reported, resulting in no-reflow and ventricular tachycardia/cardiac arrest. Following further intervention, final angiography reportedly showed TIMI 3 flow. The patient subsequently developed refractory shock and died later the same day. The cause of the acute stent thrombosis/occlusion and its potential contribution to the patient's death are under investigation. This report pertains to one of two PK Papyrus devices used during the same procedure involving the same patient and clinical event. Since it could not be determined if only one or both PKPs occluded, the second device is reported separately under manufacturer report number 8043892-2026-08115.
Patient problems: Thrombosis/Thrombus
MAUDE report 50492892 ↗MalfunctionAug 27, 2026Failure to Advance
The PK Papyrus covered stent system was selected for treatment of a lesion in the distal RCA. The device was inserted into the patient's body but could not pass the lesion. As a result, the device was removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50469883 ↗MalfunctionAug 27, 2026Failure to Advance
The PK Papyrus covered stent system was selected for treatment of a lesion in the mid LAD. The device was inserted into the patient's body but could not pass the lesion. The procedure was finished using a smaller PK Papyrus.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50469876 ↗DeathAug 24, 2026Lack of Effect
During balloon dilatation of the prox. LCX, an Ellis Type III coronary peroration occurred. Three PK Papyrus coronary covered stents were implanted in an attempt to control the bleeding. Despite the treatment performed, the perforation was reported as not successfully sealed. The patient died during the procedure due to hemorrhage from coronary perforation. The physician stated that this the bleeding might have resulted from concurrent or late micro perforation of the LAD, a small ramus branch, or the LM. The cause of the reported event is currently under investigation. This report pertains to one of three PK Papyrus devices used in the same procedure involving the same patient and clinical event. The other two devices are reported separately under MDR Report 8043892-2006-073003 and 8043892-2006-073004.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50400887 ↗DeathAug 24, 2026Lack of Effect
During balloon dilatation of the prox. LCX, an Ellis Type III coronary peroration occurred. Three PK Papyrus coronary covered stents were implanted in an attempt to control the bleeding. Despite the treatment performed, the perforation was reported as not successfully sealed. The patient died during the procedure due to hemorrhage from coronary perforation. The physician stated that this the bleeding might have resulted from concurrent or late micro perforation of the LAD, a small ramus branch, or the LM. The cause of the reported event is currently under investigation. This report pertains to one of three PK Papyrus devices used in the same procedure involving the same patient and clinical event. The other two devices are reported separately under MDR Report 8043892-2006-073004 and 8043892-2006 073005.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50400884 ↗MalfunctionApr 30, 2026Device Dislodged or Dislocated
DURING TREATMENT OF THE RCA, WHEN PERFORMING BALLOON DILATATION WITH AN NC BALLOON, A PERFORATION OCCURRED. IT WAS DECIDED TO USE A PK PAPYRUS COVERED SENT SYSTEM, BUT THE COVERED STENT WAS UNABLE TO BE DELIVERED AND DISLODGED FROM THE BALLOON. ANOTHER PK PAPYRUS STENT WAS SUCCESSFULLY DEPLOYED AND RESOLVED THE PERFORATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25039976 ↗MalfunctionApr 29, 2026Device Dislodged or Dislocated
A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN ELLIS TYPE I PERFORATION IN THE MID LAD. THE PERFORATION OCCURRED DURING IMPLANTATION OF A DES. AFTER BALLOON DILATATION. IT WAS ATTEMPTED TO ADVANCE THE COMPLIANT DEVICE BUT THIS WAS COMPLICATED BY THE STENT COMING OFF THE BALLOON. THE STENT WAS NEVER DEPLOYED AND REMAINED ON THE GUIDEWIRE AT THE TIP OF THE GUIDING CATHETER. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE SENT WITH A GOOSENECK SNARE BUT WERE UNSUCCESSFUL. FINALLY, IT WAS DECIDED TO PUSH THE STENT BACK INT THE LAD. EVENTUALLY TWO DES WERE DEPLOYED IN THE PROXIMAL TO MID LAD ADAPTING THE UNDEPLOYED COVERED STENT INTO THE VESSEL WALL. EXCELLENT RESULTS WERE ACHIEVED IN THE LAD WITH TIMI 3 FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031070 ↗MalfunctionApr 29, 2026Failure to Advance
A PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN ELLIS TYPE III PERFORATION IN THE DISTAL LAD. THE PERFORATION OCCURRED DURING IMPLANTATION OF A DES. AFTER PROTAMINE WAS GIVEN AND BALLOON DILATATION WAS PERFORMED, THE PK PAPYRUS WAS INTRODUCED, BUT IT WAS DIFFICULT TO DELIVER THE DEVICE TO THE DISTAL LAD. DURING ATTEMPT TO DELIVER, THE WIRE CAME BACK, WAS READVANCED AND THEN ABLE TO DELIVER THE PK PAPYRUS SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25027052 ↗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 ↗DeathMar 13, 2026Device Dislodged or Dislocated
THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PERFORATION IN THE LAD. WHILE DELIVERING THE STENT, IT BECAME DISLODGED FROM BALLOON CATHETER AND EMBOLIZED IN THE CORONARY ARTERY. ON THE SAME DAY, THE PATIENT PASSED AWAY DUE TO CARDIOGENIC SHOCK AND ARREST.
Patient problems: Cardiac Arrest; Cardiogenic Shock
MAUDE report 24589698 ↗MalfunctionMar 3, 2026Failure to Advance; Device Dislodged or Dislocated
THE PK PAPYRUS COVERED STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TYPE II PERFORATION IN A SIDE BRANCH OF THE RCA. AFTER PROTAMINE INJECTION, BALLOON DILATATION AND UNSUCCESSFUL COIL DELIVERY, THE COMPLAINT PK PAPYRUS WAS INTRODUCED BUT UNABLE TO BE DELIVERED. LATER, ON TABLE, THE STENT STRIPPED OFF BALLOON. SO, IT WAS DISCARDED. ANOTHER PK PAPYRUS WAS USED, AND THE LESION WAS SUCCESSFULLY SEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495173 ↗MalfunctionFeb 27, 2026Device Dislodged or Dislocated
PK PAPYRUS COVERED STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A PERFORATION IN THE LCX. THE STENT CAME OFF WHILE ADVANCING INTO THE BODY. AS IT COULD NOT BE VISUALIZED, ANOTHER PK PAPYRUS STENT WAS ATTEMPTED TO BE IMPLANTED BUT COULD NOT CROSS (REPORTED SEPARATELY). WHEN REMOVING THE SECOND DEVICE, THE DISLODGED STENT CAME OUT OF THE BODY TOGETHER WITH THE SECOND DEVICE. THE PERFORATION COULD BE SEALED WITH ANOTHER PK PAPYRUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24466610 ↗
Other Biotronik AG products
All Biotronik AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page