MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/15; COVERED CORONARY STENT

Model Number	434889
Medical Device Problem Codes	Device Slipped (1584); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
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 a severely calcified proximal om lesion.A complex high risk pci was performed and post stent angiography demonstrated a proximal lcx and proximal om1 intramural hematoma and perforation in the proximal lcx.A 3.5/15 pk papyrus covered stent was inserted, but the stent dislodged from its original position on the delivery balloon when it was unable to cross lesion.It was removed from the patient and a new 2.5/15 pk papyrus covered stent was deployed to the proximal om1 perforation.
Additional Manufacturer Narrative
Correction device code a051204: dev.Slipped, was reported in error.The correct device code a150204: failr to advance, is reported now.The affected pk papyrus stent system was returned to biotronik and subjected to a technical investigation.Images of the case such as angiographies could not be obtained.The provided clinical information (pk papyrus device registration form, hemodynamic procedure report, cardiac diagnostic & pci report, discharge summary, operative report) and the production documentation were reviewed to establish whether a device deficiency contributed to this event.The technical investigation showed that the stent is displaced on the balloon by about 2 mm in distal direction.Stent imprints on the exposed balloon surface indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The balloon is well folded and shows no signs of inflation.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 treating physician rated the occurrence as 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.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference (b)(4).The affected pk papyrus stent system was returned to biotronik and subjected to a technical investigation.Images of the case such as angiographies could not be obtained.The provided clinical information (pk papyrus device registration form, hemodynamic procedure report, cardiac diagnostic & pci report, discharge summary, operative report) and the production documentation were reviewed to establish whether a device deficiency contributed to this event.The technical investigation showed that the stent is displaced on the balloon by about 2 mm in distal direction.Stent imprints on the exposed balloon surface indicate that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The balloon is well folded and shows no signs of inflation.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 treating physician rated the occurrence as 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 3.5/15
• 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: 19051362
• Report Number: 1028232-2024-01897
• Device Sequence Number: 7355212
• Product Code: NIV
• UDI-Device Identifier: 07640130447172
• UDI-Public: (01)07640130447172(17)2407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/28/2024

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: 07/03/2024
• Device Model Number: 434889
• Device Catalogue Number: 434889
• Device Lot Number: 05226642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 10/28/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/09/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2022
• 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: 62 YR
• Patient Sex: Male