MAUDE Adverse Event Report: BIOTRONIK AG PK PAPYRUS US 2.5/15; CORONARY COVERED STENT

Model Number	434887
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Pericardial Effusion (3271)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected pk papyrus stent system was not returned and could therefore not be subjected to a technical investigation.Images of the case such as angiographies could also not be obtained.The provided clinical information (pk papyrus device registration form, cathlab report) and the production documentation were reviewed to establish whether a device deficiency contributed to this event.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the provided documentation and the conducted review no manufacturing related root cause could be identified.The treating physician rated the outcome as both no device- and no procedure-related complication.Pk papyrus is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.As such, this device is typically used in emergent response to a life-threatening adverse procedural event unrelated to use of the pk papyrus.
Event or Problem Description
It was intended to treat a severely calcified lesion in a severely tortuous part of the mid lad (70-80 % stenosis degree) with a des stent during which a coronary artery perforation type iii occurred.To stop the bleeding, balloon dilation was performed, followed by pericardiocentesis.The affected pk papyrus 2.5/15 was then introduced into the patient's body, but the stent dislodged from the balloon.However, the dislodged stent could be dilated inside the previously implanted stent.Thereafter, a pk papyrus 2.5/15 was deployed distally to the first stent with complete sealing of the tear.Eventually, the stents were post-dilated with a 3.0 nc balloon.The more proximal portion of the lad also appeared to have severe disease, likely worsened by the extension catheter due to which a des 3.0/12 mm stent was implanted overlapping the other stents.Following post dilatation, flow was lost in the jailed d2 at which the physician was unable to regain access.The d1 was also jailed but could be rewired and dilated through the stent struts with a good final result.Ivus was used for procedural guidance.After an additional treatment of a ramus lesion, the patient was admitted to micu for further monitoring while on pericardial drain.On the next day, the patient reported pain and developed expanding hematoma at the femoral artery site where the pci catheter entered.Down-trending hemoglobin was noted.External pressure was applied to the hematoma site at the right groin.The patient progressed to hypotensive shock and eventually lost the pulses.Resuscitation was performed but unsuccessful.The treating physician rated the outcome as both no device- and no procedure-related complication.

• Brand Name: PK PAPYRUS US 2.5/15
• Common Device Name: CORONARY COVERED STENT
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: tina mueller ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 22435101
• Report Number: 8043892-2025-06234
• Device Sequence Number: 19614774
• Product Code: NIV
• UDI-Device Identifier: 07640130447158
• UDI-Public: (01)07640130447158(17)260902(10)07244402
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: H17004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2026
• Device Model Number: 434887
• Device Lot Number: 07244402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown