MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.0/20; COVERED CORONARY STENT

Model Number	434896
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of a perforation during a procedure with a des.The perforation could not be sealed properly.Further information was requested but unsuccessful so far.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was provided for analysis, and the affected stent remained inside patient.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 or material related root cause could be identified.The root cause for the complaint event is therefore most likely related to external factors.It should be noted that the ifu advises the user to select the stent size to match the diameter of the vessel to achieve a final stent diameter to vessel ratio of 1 to 1 and a full coverage of the lesion over its entire length with a single stent, and to choose the stent length to avoid use of overlapping stents.

• Brand Name: PK PAPYRUS US 4.0/20
• 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: 9531416
• Report Number: 1028232-2019-05784
• Device Sequence Number: 16722742
• Product Code: NIV
• UDI-Device Identifier: 07640130447240
• UDI-Public: 07640130447240
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: 08/31/2021
• Device Model Number: 434896
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09192028
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 03/05/2020
• 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: Hospitalization
• Patient Age: 80 YR