MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/26; COVERED CORONARY STENT

Model Number	434900
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100)
Date of Event	11/01/2019
Type of Reportable Event	Death
Event or Problem Description
This report was found in an internal audit.A pk papyrus covered stent system was used to treat a perforation.Periprocedural, there was an acute in-stent thrombosis.Patient passed away two days after intervention.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was available for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no manufacturing related root cause was determined.

• Brand Name: PK PAPYRUS US 3.5/26
• Common Device Name: COVERED CORONARY STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9860026
• Report Number: 1028232-2020-01356
• Device Sequence Number: 11551926
• Product Code: NIV
• UDI-Device Identifier: 07640130447288
• UDI-Public: 07640130447288
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 02/28/2021
• Device Model Number: 434900
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03193058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 58 YR