MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 2.5/20; COVERED CORONARY STENT

Model Number	434893
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Pk papyrus covered stent was attempted to implant to cover a type iii cs/iv perforation in the lcx (occurred after rotablation) but was unsuccessful.A second attempt was made but failed, and the stent stripped off the balloon as it was being withdrawn.The stent was on the wire completely outside the left main coronary artery.At this point, given the ongoing perforation and risk of pericardial tamponade, it was decided to withdraw stent.System was removed, but it was noted that the stent was not present on the wire indicating the stent embolized beyond the arch of the aorta.Multiple attempts were performed to balloon tamponade the perfusing multiple balloons.Patient developed chest pain and echocardiogram showed a moderately large pericardial effusion.Pericardiocentesis was performed and a pericardial drain was placed.Patient received blood transfusion.Protamine was administered.At the conclusion of the procedure there was evidence that the pericardial effusion resolved completely.
Additional Manufacturer Narrative
23-oct-2024 additional information: the treating physician rated the outcome as no device- but procedure-related complication.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 were 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 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.

• Brand Name: PK PAPYRUS US 2.5/20
• 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: 20241683
• Report Number: 1028232-2024-04916
• Device Sequence Number: 8090327
• Product Code: NIV
• UDI-Device Identifier: 07640130447219
• UDI-Public: (01)07640130447219(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: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2025
• Device Model Number: 434893
• Device Catalogue Number: 434893
• Device Lot Number: 04231976
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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: Life Threatening; Required Intervention
• Patient Sex: Male