MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/20; COVERED CORONARY STENT

Model Number	434894
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent system was chosen for treatment of a type iii perforation occurred during rotablator in the mid rca.After device introduction it was not possible to deploy the stent.The device was removed intact from the patients body.
Additional Manufacturer Narrative
The affected pk papyrus stent system was returned to biotronik and was 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) was sufficient to establish whether a device deficiency contributed to this event.The 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.The technical investigation revealed that the balloon shows clear signs of inflation.Contrast medium was observed in the balloon lumen.The stent is displaced on the balloon by 2.5 mm in distal direction, is severely deformed in its proximal portion and appears slightly expanded.The stent cover is damaged due to the deformation of the stent.Microscopic inspection revealed stent imprints on the balloon surface, indicating that the stent was initially crimped centered in between the two radiopaque markers on the balloon.After rinsing, the balloon could be inflated and deflated without issues.Based on the provided documentation, technical investigation, 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 3.0/20
• 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: 14605249
• Report Number: 1028232-2022-02902
• Device Sequence Number: 17412533
• Product Code: NIV
• UDI-Device Identifier: 07640130447226
• UDI-Public: 07640130447226
• 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): 05/25/2022

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: 03/31/2023
• Device Model Number: 434894
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03216404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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