MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/26; COVERED CORONARY STENT

Model Number	434900
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Cardiogenic Shock (2262)
Date of Event	01/01/2023
Type of Reportable Event	Death
Event or Problem Description
During stenting of a severely calcified lesion with 99 percent stenosis degree in the mid rca, a type iii perforation occurred in the proximal rca.An emergent bypass and ligation of the perforation was discussed, but first controlling of the perforation with other methods was preferred.Subsequently, pk papyrus covered stents were used to seal the perforation.The sealing could be achieved with implanting the third stent.Afterwards, the severe stenosis distally was treated with two drug-eluting competitors stents.The vessel was fully revascularized, no significant stenosis, no edge dissection and not further extravasation of contrast.An impella was placed during the procedure.Following the intervention, the patient went to bypass surgery.16 days after surgery patient died due to cardiogenic shock.This complaint refers to the third stent.The other two stents are reported separately.
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, discharge summary) and the product release documentation was reviewed to establish whether a device deficiency contributed to this event.Review of the product release documentation confirmed that the devices were 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 occurrence as non-device- and non-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 3.5/26
• 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: 16363211
• Report Number: 1028232-2023-00786
• Device Sequence Number: 6748504
• Product Code: NIV
• UDI-Device Identifier: 07640130447288
• UDI-Public: (01)07640130447288(17)2307
• 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): 01/26/2023

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: 07/31/2023
• Device Model Number: 434900
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07213422
• 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: 01/26/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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 Age: 86 YR
• Patient Sex: Male