MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 4.5/20; COVERED CORONARY STENT

Model Number	434897
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	01/11/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2023, a pk papyrus covered stent system was selected for treatment of a type iii lesion in the mid rca.It was implanted without problems, and the perforation was successfully sealed.On (b)(6) 2023, patient presented to er after an out of hospital cardiac arrest.He was treated with medication and was monitored but was in no condition to go to the cath lab, and his overall prognosis was very poor.Patient passed away due to cardiopulmonary arrest and underlying stemi and acute renal failure.After review of the case by a medical director of the hospital on (b)(6) 2022, it was stated that it is possible that the patients acute inferior mi, leading to patients demise, may be due to stent thrombosis involving the pk papyrus covered stent.On (b)(6) 2023 a follow-up registration form was filed, informing about the death and the possible involvement of the pk papyrus stent thrombosis.Upon study handoff to new research coordinator, printed email correspondence regarding this case was discovered.
Additional Manufacturer Narrative
22-sep-2022 two typos occurred in the description of the initial mdr regarding the first two dates mentioned.The first three sentences should read: on (b)(6)2022 a pk papyrus covered stent system was selected for treatment of a type iii lesion in the mid rca.It was implanted without problems, and the perforation was successfully sealed.On (b)(6)2022 patient presented to er after an out of hospital cardiac arrest.He was treated with medication and was monitored but was in no condition to go to the cath lab, and his overall prognosis was very poor.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 forms of both the initial procedure and the second hospital visit, interventional cardiology notes, cathlab report, ekg, medical death note and email correspondence) 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.No device deficiency and no manufacturing related root cause was 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 4.5/20
• 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: 17777666
• Report Number: 1028232-2023-04683
• Device Sequence Number: 5492886
• Product Code: NIV
• UDI-Device Identifier: 07640130447257
• UDI-Public: (01)07640130447257(17)2212
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 434897
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01211331
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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