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

Model Number	434892
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
After treatment of a lesion with atherectomy, balloon dilatation and placement of a des in the mid rca, a perforation was detected.3 pk papyrus stents were implanted.For two hours the patient was stable but just before transferring the patient to ccu, extravasation from pericardial space was noticed.Another pk papyrus stent (complaint device) was advanced to the proximal rca, but the stent dislodged.The patient remained hemodynamically unstable and was therefore transferred to operating room.An emergent sternotomy was performed.An approx.0.5 inch tear was noticed at the rv-ra junction.Patient had svg to pda and direct repair of the rca to rv tear.
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, cathlab report) was reviewed to establish whether a device deficiency contributed to this event.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.After additional correspondence with the local staff, the hospital stated that different factors contributed to the complaint event: having prior stents, the use of a guideliner, the calcified target vessel.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: 15015365
• Report Number: 1028232-2022-03613
• Device Sequence Number: 11361726
• Product Code: NIV
• UDI-Device Identifier: 07640130447202
• UDI-Public: (01)07640130447202(17)2304
• 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): 06/20/2022

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: 04/30/2023
• Device Model Number: 434892
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04212688
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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
• Patient Age: 88 YR
• Patient Sex: Male