MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 2.5/15; COVERED CORONARY STENT

Model Number	434887
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of a type i perforation in the main branch of the lcx.To stop the bleeding balloon dilation was performed.Afterwards the complaint pk papyrus was prepared, but the stent came off the balloon outside patient.Thereafter, a pk papyrus 2.5/20 was introduced but the lesion could not be crossed, despite additional pre-dilation (reported separately).According to the cathlab report, the distal vessel was completely occluded at the conclusion of the procedure.There was no perforation detected at the conclusion of the procedure.The patient was hemodynamically stable.No grafts were placed.

• Brand Name: PK PAPYRUS US 2.5/15
• 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: 17572604
• Report Number: 1028232-2023-04165
• Device Sequence Number: 18209628
• Product Code: NIV
• UDI-Device Identifier: 07640130447158
• UDI-Public: (01)07640130447158(17)2310
• 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): 08/18/2023

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: 10/31/2023
• Device Model Number: 434887
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10210222
• 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: 08/10/2023
• Initial Report FDA Received Date: 08/18/2023
• Date Device Manufactured: 11/18/2021
• 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 Age: 75 YR
• Patient Sex: Male