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

Model Number	434893
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	09/22/2023
Type of Reportable Event	Death
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of a type iii perforation in the mid lad.The device was inserted but was removed to insert a guideliner.The stent came off during removal.Patient passed away two days later due to cardiogenic shock.The physician rated the death as not device related.
Additional Manufacturer Narrative
To stop the bleeding balloon dilation / balloon tamponade was performed.A pk papyrus 3.5/20 was inserted but then removed in order to insert a pk papyrus 3.0/20 by use of a 6f guideliner v2 extension catheter.The pk papyrus 3.0/20 was deployed successfully.Thereafter, an onyx frontier 2.75 x 15 mm stent system was inserted, followed by the complaint instrument.The stent dislodged from the balloon but could be removed from the patients body.Eventually, the extension catheter was removed, and the perforation was sealed successfully by use of a sprinter 2.25 x 15 mm balloon and a pk papyrus 2.5/20.The patient developed a peri-procedural myocardial infarction and passed away two days after the intervention due to cardiogenic shock.The affected pk papyrus stent system was returned to biotronik and subjected to a detailed technical investigation.Images of the case such as angiographies could 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.In the as-returned state the stent was located on the balloon, displaced by about 19 mm in distal direction.The stent is severely deformed (i.E.Compressed) in its center.The balloon is well folded and shows no signs of inflation but contrast medium residue was observed in the balloon- and inflation lumen which is indicative for the application of vacuum and may have contributed to the complaint event.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.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 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: 17916434
• Report Number: 1028232-2023-05171
• Device Sequence Number: 12458104
• Product Code: NIV
• UDI-Device Identifier: 07640130447219
• UDI-Public: (01)07640130447219(17)2504
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2025
• Device Model Number: 434893
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03233921
• Was Device Available for Evaluation?: Yes
• 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: 11/01/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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: Death
• Patient Age: 64 YR
• Patient Sex: Female