MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.5/20; COVERED CORONARY STENT

Model Number	434895
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A severely calcified lesion in the lad was treated with rotational atherectomy and pre-stent angioplasty with multiple balloons, followed by stenting with 3 des in overlapping manner.A type ii perforation occurred but then progressed to a type iii perforation.Three pk papyrus stents were implanted but in the middle stent (3.5/20) a leak/tear was noticed.An additional pk papyrus was implanted which resulted in a complete sealing.
Additional Manufacturer Narrative
After detecting the hole in the mid pkp, three additional pk papyrus stents were implanted in an overlapping manner.After subsequent balloon dilation the perforation was sealed successfully.Within 48 hours after the intervention a pericardial drain was placed due to a small pericardial effusion.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) 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 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.Considering the description in the cathlab report, the root cause for the complaint event is most likely related to the patients anatomy (i.E.Cutting of calcium through the stent).The treating physician rated the outcome as device- but not 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 3.5/20
• 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: 17325651
• Report Number: 1028232-2023-03532
• Device Sequence Number: 14863231
• Product Code: NIV
• UDI-Device Identifier: 07640130447233
• UDI-Public: (01)07640130447233(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): 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 434895
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07212909
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male