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	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Pk papyrus covered stent system was selected for treatment of a type iii perforation of the mid rca after use of atherectomy.Pk papyrus was inserted into the guide, passed through and it was noted that the stent was not on the balloon when in the vessel.The stent was located in the guide catheter.Two other pk papyrus stents were implanted, and the perforation was successfully sealed.
Additional Manufacturer Narrative
The affected pk papyrus stent system was returned to biotronik and subjected to a technical investigation.The provided clinical information (pk papyrus device registration form) and the production documentation were reviewed to establish whether a device deficiency contributed to this event.The delivery system and the stent were returned separately.The balloon is well folded and shows no signs of inflation.However, dried contrast medium residue was observed in the balloon- and inflation lumen which is indicative for the application of vacuum.Stent imprints on the exposed balloon surface further indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The returned stent is severely deformed, i.E.One side is flat.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 provided documentation and the conducted investigation, no manufacturing related root cause could be identified.The application of vacuum may have contributed to the reported event.The treating physician rated the occurrence as no device- but 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.
Additional Manufacturer Narrative
Reference capa# (b)(4).The affected pk papyrus stent system was returned to biotronik and subjected to a technical investigation.The provided clinical information (pk papyrus device registration form) and the production documentation were reviewed to establish whether a device deficiency contributed to this event.The delivery system and the stent were returned separately.The balloon is well folded and shows no signs of inflation.However, dried contrast medium residue was observed in the balloon- and inflation lumen which is indicative for the application of vacuum.Stent imprints on the exposed balloon surface further indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The returned stent is severely deformed, i.E.One side is flat.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 provided documentation and the conducted investigation, no manufacturing related root cause could be identified.The application of vacuum may have contributed to the reported event.The treating physician rated the occurrence as no device- but 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 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: 19277047
• Report Number: 1028232-2024-02574
• Device Sequence Number: 20413137
• Product Code: NIV
• UDI-Device Identifier: 07640130447158
• UDI-Public: (01)07640130447158(17)2509
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

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: 09/11/2025
• Device Model Number: 434887
• Device Catalogue Number: 434887
• Device Lot Number: 08230068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 10/29/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/04/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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: 79 YR
• Patient Sex: Male