MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/15; COVERED CORONARY STENT

Model Number	434888
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
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, admission note, image of stents) was reviewed to establish whether a device deficiency contributed to this event.The provided photograph of two dislodged stents was reviewed.Two deformed stents are visible.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.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.
Event or Problem Description
Initially, a wrong lot number and size (lot 02192475 / pk papyrus us 3.0/20) was reported on mdr (b)(4).After clarification, it could be shown that in the pk papyrus size 3.0/15 only one lot (03216395) was ever delivered to the respective hospital and was defined as the complaint lot.Multiple passes with rotapro (rotational atherectomy) due to severely calcification (60 percent stenosis degree) lead to type iii perforation of proximal to mid lad.The pk papyrus covered stent system was selected for treatment of the perforation.Initially, it was tried a block-and-deliver technique (placed a second wire, bmw) into the distal lad, and over this tried to deliver the pk papyrus, but this stripped off.The stent could be retrieved.Three other pk papyrus stents were implanted, and the perforation was successfully sealed.

• Brand Name: PK PAPYRUS US 3.0/15
• 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: 15931533
• Report Number: 1028232-2022-06201
• Device Sequence Number: 4384621
• Product Code: NIV
• UDI-Device Identifier: 07640130447165
• UDI-Public: (01)07640130447165(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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2022

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: 03/31/2023
• Device Model Number: 434888
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03216395
• 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: 12/06/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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: Hospitalization
• Patient Sex: Female