MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 2.5/20; COVERED CORONARY STENT

Model Number	434893
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2024
Type of Reportable Event	Malfunction
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, patient information report) and the production documentation 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 provided documentation and the conducted review, no manufacturing related root cause could be identified.The treating physician rated the occurrence as not device- and not 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.
Event or Problem Description
During an emergency case, it was intended to treat a moderately calcified lesion (100 percent stenosis degree) in a mildly tortuous segment of a side branch of the medial lcx.The patient was under constant defibrillation, intubated and sedated during the entire intervention.During lesion preparation and access with a guide wire, a coronary artery perforation type iii occurred.Perforation mechanism: guide wire.To stop the bleeding, several balloon dilations with up to 10 minutes were performed, and a pericardial drain was placed.Thereafter, under use of a 7f ebu guiding catheter and a 7f introducer sheath, the pk papyrus 2.5/20 was advanced towards the target perforation but was unable to cross the target area.During withdrawal, the stent of the complaint device dislodged from the balloon (reported separately).It was reported that both, the delivery system and the dislodged stent, were safely removed from the patient.As the bleeding persists, the complaint pk papyrus 2.5/20 of the same lot was selected and was advanced towards the target perforation but was unable to cross the target area and had to be removed.After withdrawal, it was noticed that the stent became deformed.It was decided not to re-insert the deformed stent.A 3.0/20 pk papyrus was safely delivered and successfully implanted to stop the bleeding.
Additional Manufacturer Narrative
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, patient information report) and the production documentation 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 provided documentation and the conducted review, no manufacturing related root cause could be identified.The treating physician rated the occurrence as not device- and not 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 2.5/20
• 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: 19669137
• Report Number: 1028232-2024-03567
• Device Sequence Number: 6835784
• Product Code: NIV
• UDI-Device Identifier: 07640130447219
• UDI-Public: (01)07640130447219(17)2409
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 11/20/2024

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: 09/19/2024
• Device Model Number: 434893
• Device Catalogue Number: 434893
• Device Lot Number: 08224921
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male