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

Model Number	434900
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	09/22/2022
Type of Reportable Event	Death
Event or Problem Description
After performing a pci of the lad and deploying a drug-eluting stent system, a large perforation in the distal segment with active extravasation into the pericardium was detected.Thus, a pk papyrus stent system was placed which could not completely stop the bleeding.The patient was quickly in cardiac tamponade and while preparing for pericardiocentesis, the stented segments thrombosed with clot extending towards the left main.Aspiration thrombectomy was performed and additional vessel ruptures were noted which were treated with three more pk papyrus stent systems.There was still a bit of micro blush in the proximal segment of the lad and because of the use of the pkps, multiple side branches including the septals were jailed off.The patient died 3 days later which was not device related.This is three of four reports.Device code is (b)(4).
Additional Manufacturer Narrative
The affected pk papyrus stent systems were not returned to biotronik and could therefore not be subjected to a technical investigation.Images of the case such as angiographies could also not be obtained.The provided clinical information (pk papyrus device registration form, cathlab report) was reviewed to establish whether a device deficiency contributed to this event.The review of the product release documentation confirmed that the devices were manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the provided documentation and the conducted review no manufacturing related root cause could be identified.It should be noted that the ifu advises the user to hold the inflation pressure for 15-30 seconds and not to exceed the balloon rated burst pressure (rbp).The treating physician rated the occurrence not as a device-related complication but as a procedure-related complication.Pk papyrus is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.As such, this device is typically used in emergent response to a life-threatening adverse procedural event unrelated to use of the pk papyrus.

• 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
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15588222
• Report Number: 1028232-2022-05252
• Device Sequence Number: 11444301
• Product Code: NIV
• UDI-Device Identifier: 07640130447288
• UDI-Public: (01)07640130447288(17)2402
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 02/29/2024
• Device Model Number: 434900
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01226612
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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: 79 YR
• Patient Sex: Female