MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/15; COVERED CORONARY STENT

Model Number	434889
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Multiple Organ Dysfunction Syndrome (3261)
Date of Event	10/16/2024
Type of Reportable Event	Death
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of type iiics/iv perforation in the proximal lad.To stop the bleeding, balloon dilation was performed.Thereafter, the affected pk papyrus was introduced into the patients body, but the stent dislodged from the balloon prior to deployment.A second pk papyrus was implanted to cover the undeployed stent.The perforation was successfully sealed.However, the patient suffered from pericardial tamponade due to which a pericardial drain was inserted.Also, resuscitation was performed.5 days later the patient passed away due to multi system organ failure.It was stated that the death was not attributed to the pk papyrus.
Additional Manufacturer Narrative
The affected pk papyrus stent system was not returned to biotronik 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) 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.

• Brand Name: PK PAPYRUS US 3.5/15
• Common Device Name: COVERED CORONARY STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 20827586
• Report Number: 1028232-2024-06211
• Device Sequence Number: 9831135
• Product Code: NIV
• UDI-Device Identifier: 07640130447172
• UDI-Public: (01)07640130447172(17)2509
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 09/18/2025
• Device Model Number: 434889
• Device Catalogue Number: 434889
• Device Lot Number: 08232057
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 80 YR
• Patient Sex: Female