MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/15; COVERED CORONARY STENT

Model Number	434888
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	12/14/2021
Type of Reportable Event	Death
Event or Problem Description
An atherectomy at low speed was performed when a large perforation in the mid lad was detected.Ballooning and a pericardiocentesis draining was performed.Two pk papyrus covered stents were implanted, but the bleeding extended down further in the lad.The patient was intubated and an impella was placed, but the bleeding did not stop.The lad was coiled with multiple penumbra coils.The patient stabilized and the bleeding was resolved.Patient left on impella and intubated.Patients family declined further care in icu.Two days after the intervention the patient passed away.Other pk papyrus stent is reported separately.
Additional Manufacturer Narrative
The affected pk papyrus stent system was 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.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections during which a 100 percent control of the stent cover is performed.Based on the provided documentation and the conducted review no device deficiency or manufacturing related root cause for the reported potentially insufficient sealing of the perforation could be identified.The information provided in the pk papyrus device registration form stated that there was no device or 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 3.0/15
• 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: 13765117
• Report Number: 1028232-2022-01255
• Device Sequence Number: 12010380
• Product Code: NIV
• UDI-Device Identifier: 07640130447165
• UDI-Public: 07640130447165
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 434888
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06213536
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• 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: Male