MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.0/20; COVERED CORONARY STENT

Model Number	434896
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/15/2022
Type of Reportable Event	Death
Event or Problem Description
One month before the complaint event on (b)(6) 2022, the patient was successfully treated by stenting in the medial lcx.At the event date, due to chest pain, the patient underwent a diagnostic angiography to prepare an rca stenting.During the diagnostic angiography a type iii cs/iv perforation in the lm occurred with a large pericardial effusion and the patient became unstable.A pericardial drain was placed, and a significant amount of blood was evacuated from the pericardial space.An emergency sternotomy was performed.The alleged perforation was identified in the ostial to proximal lad.To stop the bleeding a vein graft was implanted to graft the lad.After additional angiographies, it was noted that the actual perforation is not in the lad but in the lm.The complaint stent was chosen and implanted across the perforation in the lm and post dilated, but the bleeding situation could not be stopped.The situation has worsened more, as the tear was now near the lm ostium and it was planned to replace the aortic root.During the preparation for that, a significant venous bleeding in the abdomen was noticed.The situation was agreed not to be a salvageable situation and after discussion with the family it was decided to withdraw the support systems and the patient died.In the death summary, it was stated that the patients tissues seemed to be very friable.It was clarified that there is a family history of connective tissue disease.The information provided in the pk papyrus device registration form stated that there was no device-related complication but a procedure-related complication from the diagnostic angiography.(b)(4).
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.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections during which a 100 percent control of the stent cover is performed.Based on the provided documentation and the conducted review no device deficiency or manufacturing related root cause for the reported potentially insufficient sealing of the perforation could be identified.The information provided in the pk papyrus device registration form stated that there was no device or procedure-related complication.The physician stated that the patients tissue seemed to be very friable and that there is a family history of connective tissue disease which might have been a contributing factor for the complaint event.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 4.0/20
• 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: 15529794
• Report Number: 1028232-2022-05073
• Device Sequence Number: 16770808
• Product Code: NIV
• UDI-Device Identifier: 07640130447240
• UDI-Public: (01)07640130447240(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
• Report Date (Section B): 09/22/2022

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: 434896
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02214099
• 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: 09/22/2022
• Initial Report FDA Received Date: 10/03/2022
• Date Device Manufactured: 03/26/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Male