MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.0/15; COVERED CORONARY STENT

Model Number	434890
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Shock (2072)
Date of Event	08/11/2023
Type of Reportable Event	Death
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) and the product release documentation were reviewed to establish whether a device deficiency contributed to this event.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.The treating physician rated the occurrence as both no device- and no 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.
Event or Problem Description
The intention was to treat a lesion in the proximal lcx by rotablation during which a coronary artery perforation type iii occurred.To stop the bleeding balloon dilation was performed.A pk papyrus us 3.0/20 was introduced into the patients body and inflated with 8 atm.However, the perforation was not sealed successfully (reported separately).Therefore, both a drug eluting stent and the complaint pk papyrus us 4.0/15 were implanted, but still the perforation could not be sealed, despite post-dilation with two balloons.Thereafter, the patient underwent an emergent cabg and passed away due to hemorrhagic shock.

• Brand Name: PK PAPYRUS US 4.0/15
• 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: 17638691
• Report Number: 1028232-2023-04272
• Device Sequence Number: 5590441
• Product Code: NIV
• UDI-Device Identifier: 07640130447189
• UDI-Public: (01)07640130447189(17)2409
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2023

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: 09/12/2024
• Device Model Number: 434890
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08224910
• 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: Not provided
• Initial Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: 82 YR
• Patient Sex: Female