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

Model Number	434899
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	06/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The pk papyrus us covered stent system was chosen to seal a very large perforation.The perforation which occurred on a giant piece of calcium hit with a rotablator was in the proximal lad in a vessel that is occluded mid lad and in a diagonal, supplying many septals of the rca to seal the perforation bifurcation stenting was done, but the lad perforation was not fully covered by the 2nd pk papyrus placed from lm into the lad.Therefore 3rd was placed left main into cx.Due to covering the lad which was necessary to seal and survive the perforation the patient had a procedural myocardial infarction.All three pk papyrus us stents were properly deployed.There was no malfunction of the device.It is not known which of the three placed pk papyrus us, which had to be placed during the intervention to save the patients life, possibly led to procedural myocardial infarction.3 stents reported on mdr-1028232-2020-02866, and mdr-1028232-2020-02868.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was provided 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 for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no manufacturing related root cause could be identified.It should be noted that, according to the physician, the pk papyrus us was properly deployed and the perforation was successfully sealed.There was no malfunction of the device.It should further be noted that the ifu states risk of treatment related occlusion of vital coronary artery side branches as contraindication for pk papyrus and stenting in general.

• 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
• MDR Report Key: 10273863
• Report Number: 1028232-2020-02867
• Device Sequence Number: 11605822
• Product Code: NIV
• UDI-Device Identifier: 07640130447271
• UDI-Public: 07640130447271
• 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): 06/15/2020

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: 09/30/2021
• Device Model Number: 434899
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09192034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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; Life Threatening