MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.0/15; COVERED CORONARY STENT

Model Number	434890
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Lack of Effect (4065)
Health Effect - Clinical Codes	Hematoma (1884); Cardiac Tamponade (2226)
Date of Event	11/15/2023
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) 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 occurrence as no device- but 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 physician intended to treat a lesion in the proximal lad with a des and a post-dilation balloon during which a coronary artery perforation type iii occurred.To stop the bleeding, both balloon dilation and protamine injection were performed.Thereafter, the affected pk papyrus 4.0/15 was implanted but the sealing was incomplete requiring an additional covered stent.Therefore, a pk papyrus us 3.5/15 was implanted and sealed the perforation successfully.The patient was transferred to icu.Several hours later, a pericardial hematoma occurred causing pericardial tamponade requiring surgical evacuation.The patient underwent resuscitation but eventually passed away.After additional correspondence with the local staff, it was clarified that the patient received a temporary pacemaker placement overnight due to alternating conduction abnormalities with predominantly junctional rhythm.The ecgs were reviewed with evidence of alternating conduction abnormalities, possible junctional bigeminy, sinus tachycardia with 2:1 block and junctional escape, and junctional rhythms hr in the 70s-80s.In addition, the patient was on multiple pressors and maps continued to be borderline.The case was discussed with an ep fellow who recommended temporary pacemaker placement overnight.Upon arrival, it was noted that the patient hemodynamically decompensated with concerns for mediastinal bleed, and the chest was opened at the bedside.The patient subsequently arrested and was pronounced by the overnight ct surgeon.The treating physician rated the occurrence as no device- but procedure-related complication.

• Brand Name: PK PAPYRUS US 4.0/15
• 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: 18311542
• Report Number: 1028232-2023-06267
• Device Sequence Number: 12331692
• Product Code: NIV
• UDI-Device Identifier: 07640130447189
• UDI-Public: (01)07640130447189(17)2505
• 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
• Report Date (Section B): 12/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2025
• Device Model Number: 434890
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04231342
• 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: 11/22/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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 Sex: Female