MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 5.0/15; COVERED CORONARY STENT

Model Number	434892
Health Effect - Clinical Codes	Myocardial Infarction (1969); Cardiac Tamponade (2226)
Date of Event	09/27/2022
Type of Reportable Event	Death
Event or Problem Description
Two pk papyrus covered stents were used for treatment of a type iii perforation in the left main, but with incomplete sealing.There was pericardial tamponade with ongoing bleeding.Patient expired.The event was described by the physician as not device or procedure related.The other pk papyrus is filed separately.(b)(4).
Additional Manufacturer Narrative
The affected pk papyrus stent systems were 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) was reviewed to establish whether a device deficiency contributed to this event.The review of the product release documentation confirmed that the devices were 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.It should be noted that the ifu advises the user to hold the inflation pressure for 15-30 seconds.The treating physician rated the outcome as not device related and not 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 5.0/15
• 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: 15626458
• Report Number: 1028232-2022-05318
• Device Sequence Number: 5978767
• Product Code: NIV
• UDI-Device Identifier: 07640130447202
• UDI-Public: (01)07640130447202(17)2302
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 02/28/2023
• Device Model Number: 434892
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02212875
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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; Hospitalization
• Patient Sex: Female