MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.5/26; COVERED CORONARY STENT

Model Number	434902
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent system was attempted to be placed in left profunda and became dislodged upon entry in the left brachial artery.Stent was retrieved with a snare without complication.
Additional Manufacturer Narrative
07-feb-2024 updated description.Between (b)(6)2023, the patient underwent different interventions during which she received a semi-permanent va ecmo device.On 06-jan-2024 an intervention was planned to remove the va ecmo equipment from the patient during which the complaint pk papyrus covered stent system would be used for assisting the closure of the access point to the left profunda artery.The pk papyrus was attempted to be placed in left profunda and became dislodged upon entry in the left brachial artery.Stent was retrieved with a snare without complication.The sheath in the left profunda was left sutured in place at the end of the intervention.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 production documentation were 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 provided documentation and the conducted review no manufacturing related root cause could be identified.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
07-feb-2024 updated description between (b)(6) 2023 the patient underwent different interventions during which she received a semi-permanent va ecmo device.On (b)(6) 2024 an intervention was planned to remove the va ecmo equipment from the patient during which the complaint pk papyrus covered stent system would be used for assisting the closure of the access point to the left profunda artery.The pk papyrus was attempted to be placed in left profunda and became dislodged upon entry in the left brachial artery.Stent was retrieved with a snare without complication.The sheath in the left profunda was left sutured in place at the end of the intervention.Corrected the initial reporter information.Reference capa# nc-24-004.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 production documentation were 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 provided documentation and the conducted review no manufacturing related root cause could be identified.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 4.5/26
• 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: 18558267
• Report Number: 1028232-2024-00402
• Device Sequence Number: 6412457
• Product Code: NIV
• UDI-Device Identifier: 07640130447301
• UDI-Public: (01)07640130447301(17)2502
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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: 02/21/2025
• Device Model Number: 434902
• Device Catalogue Number: 434902
• Device Lot Number: 01232868
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/07/2024; 10/15/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/07/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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 Sex: Female