MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 5.0/15; COVERED CORONARY STENT

Model Number	434892
Health Effect - Clinical Codes	Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Date of Event	09/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A coronary angiography was performed including using a shockwave balloon in a svg.The angiogram showed a perforation in the venous graft at the site of the shockwave therapy.An attempt was made to seal the perforation with a pk papyrus covered stent system, but it could not be delivered and the stent was lost (reported separately).The complaint pk papyrus device was deployed but could not seal the 12mm long perforation completely.The patient condition deteriorated, a thrombus was detected as procedure related complication and surgery was discussed but in view of patients history it was decided against it.Patient was shifted to ccu.Device code is (b)(4).
Additional Manufacturer Narrative
The affected pk papyrus stent system was not returned to biotronik and could therefore not be subjected to a technical investigation.Images of the case such as angiographies could also not be obtained.The provided clinical information (pk papyrus device registration form and 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.Based on the provided documentation and the conducted review no manufacturing related root cause could be identified.The treating physician rated the outcome not as a device related but as a 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 5.0/15
• 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: 15670627
• Report Number: 1028232-2022-05460
• Device Sequence Number: 20448760
• Product Code: NIV
• UDI-Device Identifier: 07640130447202
• UDI-Public: (01)07640130447202(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
• Device Implanted Year: 2022
• 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): 10/05/2022

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: 03/31/2023
• Device Model Number: 434892
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03211113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2021
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male