MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/26; COVERED CORONARY STENT

Model Number	434899
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226)
Date of Event	10/13/2022
Type of Reportable Event	Death
Event or Problem Description
After placing a stent in the mid lad in a pre-dilated total occlusion and subsequently performed post dilatation, a type iii perforation was detected.The pk papyrus covered stent system was selected for treatment of the perforation.The perforation worsened after balloon dilation and pk papyrus deployment.The tear was extended in both directions, proximally and predominantly distal to the vessel.Cardiac tamponade and pea arrest occurred.Attempted ecmo placement, without success.Patient expired in the cath lab.
Additional Manufacturer Narrative
(b)(6) 2022 opened in error.Wrong device reported.Closing report and opening new report on correct device.

• Brand Name: PK PAPYRUS US 3.0/26
• 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: 15798387
• Report Number: 1028232-2022-05817
• Device Sequence Number: 4754150
• Product Code: NIV
• UDI-Device Identifier: 07640130447271
• UDI-Public: (01)07640130447271(17)2309
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 434899
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08203280
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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: 66 YR
• Patient Sex: Male