MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/26; COVERED CORONARY STENT

Model Number	434899
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of a moderately calcified lesion in a moderately tortuous proximal vessel.The proximal edge of the stent flared due to calcification.The stent was removed, and another pk papyrus was opened and was used to repair the perforation.
Additional Manufacturer Narrative
The affected pk papyrus stent system was returned to biotronik and subjected to a detailed technical investigation.Images of the case such as angiographies could not be obtained.The technical investigation revealed that the stent is displaced on the balloon in distal direction by 5 mm.Stent imprints are visible on the exposed balloon surface, indicating that the stent was initially crimped centered between the two x-ray markers on the balloon.In addition, the stent is severely deformed at the proximal end, several stent struts are listed and everted.Further, dried contrast medium residue was observed up to the proximal balloon weld.The provided clinical information (pk papyrus device registration form, the cathlab report, and the discharge summary) was reviewed to establish whether a device deficiency contributed to this event.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations and the review of the provided documentation, no manufacturing related root cause could be identified.Considering the physicians description of the vessel morphology, the root cause for the complaint event is most likely related to the patients anatomy (i.E., severely calcified lesion).The treating physician rated the occurrence as a non-device-related and a non-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 3.0/26
• 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: 18188714
• Report Number: 1028232-2023-05944
• Device Sequence Number: 20636880
• Product Code: NIV
• UDI-Device Identifier: 07640130447271
• UDI-Public: (01)07640130447271(17)2311
• 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): 12/27/2023

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: 11/30/2023
• Device Model Number: 434899
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11216853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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
• Patient Sex: Unknown