MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/20; COVERED CORONARY STENT

Model Number	434895
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiogenic Shock (2262)
Date of Event	02/27/2023
Type of Reportable Event	Death
Event or Problem Description
This was a very high-risk pci with a type ii perforation in the left main after csi atherectomy.The bleeding was not resolve after balloon inflation and stenting.The pk papyrus covered stent was placed, but there was persistent effusion distal to the stent.Pericardiocentesis was performed.Patient developed cardiac arrest and required multiple rounds of cpr.Patient was intubated and a pericardiocentesis was performed followed by temporary pacemaker placement.Patient continued to spiral down into cardiogenic shock.Further multiple rounds of cpr for over one hour were performed.After additional prolonged balloon inflation and implantation of another pk papyrus stent, the bleeding was stopped, but patient was in cardiac standstill.
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) was reviewed to establish whether a device deficiency contributed to this event.The review of the product release 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 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 3.5/20
• 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: 16553021
• Report Number: 1028232-2023-01323
• Device Sequence Number: 4991312
• Product Code: NIV
• UDI-Device Identifier: 07640130447233
• UDI-Public: (01)07640130447233(17)2312
• 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: 2023
• 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): 04/27/2023

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: 12/31/2023
• Device Model Number: 434895
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01222050
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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: 70 YR
• Patient Sex: Female