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

Model Number	434888
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Pk papyrus covered stent systems were selected for treatment of a type iii cs/iv perforation in the mid lad.This is the third of three pk papyrus covered stents that failed to seal in the mid lad.Each is reported separately.
Additional Manufacturer Narrative
Additional event information: the physician then implanted a pk papyrus 3.5/15, a pk papyrus 3.0/15 distally and a pk papyrus 4.0/15 proximally, all in an overlapping manner.The overall maximum pressure applied was 16 atm.However, the perforation could not be sealed.Eventually, another papyrus was placed across the origin of the mid lad just after the takeoff of the 1d with 16 atm and post-dilated proximally with a 3.75 x 18 mm emerge nc balloon.In addition, a 2.5 x 16 mm stent was placed proximally within the diagonal.Final angiogram demonstrated very minimal flow into the lad.There was timi flow 3 in the d1.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 was 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.

• 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: 17735880
• Report Number: 1028232-2023-04534
• Device Sequence Number: 5519060
• Product Code: NIV
• UDI-Device Identifier: 07640130447165
• UDI-Public: (01)07640130447165(17)2401
• 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,Followup
• Report Date (Section B): 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 434888
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01226603
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male