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

Model Number	434888
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Pk papyrus covered stent systems (pkp) were selected for treatment of a type ii perforation in the mid lad.The first pkp was attempted to be introduced with the help of a guideliner device.Several attempts were unsuccessful.The pkp was pulled back in guideliner and resistance was felt, so everything was taken out together.When all was back on the table, it was attempted to use a new guideliner but the same pkp.During removal of the pkp from guideliner back on table, the pkp delivery system came out, but the stent stayed inside the guideliner.A new guideliner was used, and it was proceeded to ballooning the perforation site several times.Then a new pkp (2nd) was used and was successfully delivered, but further bleeding was detected.A 3rd pk papyrus was introduced but could not cross and was therefore withdrawn.The bleeding was then treated with prolonged balloon inflation.At that time the bleeding stopped, and the perforation was successfully sealed.Patient is fine and has recovered.This refers to the 3rd pk papyrus.The other two pkps are reported separately.
Additional Manufacturer Narrative
The affected pk papyrus stent system was 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 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 review no manufacturing related root cause could be identified.The treating physician rated the outcome 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: 17325561
• Report Number: 1028232-2023-03531
• Device Sequence Number: 12139903
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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: 01222037
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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: 68 YR
• Patient Sex: Female