MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.5/20; COVERED CORONARY STENT

Model Number	434897
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The pk papyrus was implanted successfully in the svg with no complaints.The day after implantation, it was detected that the device had expired 3 months ago.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was returned 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.The print samples of the inner as well as the outer label have been reviewed on the route card.Both labels show the identical use by date 28.Feb.2021.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 or material related root cause could be identified.It should be noted that the ifu clearly states no to use device after the use by date indicated on the label.Further the ifu states not to exceed the rated burst pressure (rbp).

• Brand Name: PK PAPYRUS US 4.5/20
• 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: 11863033
• Report Number: 1028232-2021-02770
• Device Sequence Number: 16976264
• Product Code: NIV
• UDI-Device Identifier: 07640130447257
• UDI-Public: 07640130447257
• 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: 2021
• 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): 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 434897
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03193055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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: Hospitalization
• Patient Age: 83 YR