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

Model Number	434889
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During treatment of a perforation in the lad, the pk papyrus covered stent system broke in two parts and one portion of the stent remained inside the patient.Patient was transferred to medicaid managed care (mmc) for a coronary artery bypass grafting (cabg).
Additional Manufacturer Narrative
(b)(6) 2023 the exact sequence in which the instruments where used in the patient could not be reconstructed as the hospital did not provide any further information about this case.The physician intended to treat a severely calcified lesion (99 percent stenosis degree, 3.0 mm reference vessel diameter, 20 mm lesion length) in a severely tortuous part of the proximal to medial lad during which a coronary artery perforation occurred (no perforation details available as the hospital refused to provide further information).One pk papyrus (3.0/15, unknown lot) was successfully implanted in order to seal the perforation.Another pk papyrus (reported under 1028232-2023-03389) was attempted to be implanted to further seal the perforation but dislodged unnoticed inside of the abbott copilot hemostatic valve.According to the provided information, the complaint instrument was introduced into the patients body and was advanced towards the target lesion.It is reported that the shaft of the complaint instrument broke, and the distal part remained inside of the patient.It could not be clarified if the shaft broke during the advancement or during withdrawal.The distal fragment could not be retrieved, and the patient had to be transferred to another hospital for cabg surgery.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, follow-up form) was reviewed to establish whether a device deficiency contributed to this event.The technical investigation revealed that the hypotube has fractured about 108.8 cm distal to the kink protector.At the fracture sites the cross-section of the hypotube is no longer circular but compressed into an ellipse and the polymer coating is plastically deformed.In addition, the hypotube was found kinked close to the fracture site.The findings indicate that the hypotube most probably fractured as a result of significant force.The distal fragment was not returned.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 conducted investigations and the review of the provided documentation, no manufacturing related root cause could be identified.The root cause for the complaint event is most likely related to the handling of the device.Please note that the ifu advises the user to exercise care during device handling to reduce the possibility of accidental breakage, bending or kinking of the stent system shaft.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: 16848157
• Report Number: 1028232-2023-02181
• Device Sequence Number: 7637211
• Product Code: NIV
• UDI-Device Identifier: 07640130447172
• UDI-Public: (01)07640130447172(17)2411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H170004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/20/2023

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: 11/08/2024
• Device Model Number: 434889
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10221649
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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 Age: 71 YR
• Patient Sex: Female