MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.5/15; COVERED CORONARY STENT

Model Number	434891
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
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.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
A pk papyrus covered stent system was selected for treatment of a lesion in the proximal lad.The lesion was prepared with both a balloon and a shockwave balloon.A des stent was implanted and post-dilated with a nc balloon during which a coronary artery perforation occurred.Pericardial tamponade was ensued due to rapid bleeding into the pericardium, and emergent pericardiocentesis was performed by implantation of a pk papyrus 4.0/15 at the distal end of the previously implanted stent, but it did not cover the lad perforation.The patient developed cardiogenic shock requiring emergent intubation and initiation of three vasopressors.The complaint pk papyrus was introduced into the patients body, but the stent dislodged from the balloon.The stent was snared successfully.Also, a pk papyrus us 3.5/15 was introduced into the patients body but again the stent dislodged from the balloon (reported separately).The dislodged stent was then removed from the patients body by use of a balloon.Eventually, the perforation eventually resolved on its own.The target vessel was again dilated with a balloon and another des stent was implanted.However, the patient was in cardiogenic shock and was transferred to the icu.

• Brand Name: PK PAPYRUS US 4.5/15
• 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: 17415932
• Report Number: 1028232-2023-03797
• Device Sequence Number: 7038017
• Product Code: NIV
• UDI-Device Identifier: 07640130447196
• UDI-Public: (01)07640130447196(17)2308
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 434891
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07213406
• 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: 07/10/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female