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

Model Number	434894
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of type iii perforation in the mid rca.The pk papyrus 3.0/20 could not pass through a 6f guiding catheter.Another pk papyrus 2.5/15 could not pass the lesion (event reported separately).A third pk papyrus stent was implanted which sealed the perforation successfully.The patient was hemodynamically stable.Two days after the intervention the patient deceased due to multisystem organ failure, not related to the event.
Additional Manufacturer Narrative
Udi: (b)(4).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, cathlab report) 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 is still well folded and shows no signs of inflation.The stent is displaced by 7 mm in distal direction and is severely deformed at its proximal end.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.Based on the provided documentation, the 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: 14919705
• Report Number: 1028232-2022-03403
• Device Sequence Number: 1990013
• Product Code: NIV
• UDI-Device Identifier: 07640130447226
• UDI-Public: (01)07640130447226(17)2303
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/10/2022
• 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: Death
• Patient Sex: Unknown