MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/20; COVERED CORONARY STENT

Model Number	434894
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiogenic Shock (2262)
Date of Event	03/29/2024
Type of Reportable Event	Death
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, cathlab report) and the production documentation was 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
The procedure was reported as an extremely complex case with a total duration of more than eight hours.After the placement of an impella, an attempt was made to preserve the lad to d1 bifurcation.Numerous conventional and specialized wires as well as directed micro and twin catheters were used to cross the severely calcified and angulated lesion at the ostium of d1 without success.During the subsequent stenting of the mid lad to lmca, a coronary artery perforation type iii occurred.The affected device was introduced, but the stent became deformed.Two other pk papyrus (3.0/15) were implanted in an overlapping manner which successfully sealed the perforation after post-dilation.After the procedure the patient was transferred to the icu.On the same day he developed incessant ventricular tachycardia and subsequently pulseless electrical activity.Despite valiant and prolonged efforts at resuscitation, the patient passed away due to cardiogenic shock and pea arrest.The treating physician rated the outcome as both no device- and no procedure-related complication.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.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, cathlab report) and the production documentation was 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 3.0/20
• 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: 19547274
• Report Number: 1028232-2024-03210
• Device Sequence Number: 20017200
• Product Code: NIV
• UDI-Device Identifier: 07640130447226
• UDI-Public: (01)07640130447226(17)2409
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 11/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2024
• Device Model Number: 434894
• Device Catalogue Number: 434894
• Device Lot Number: 08224914
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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: 86 YR
• Patient Sex: Male