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

Model Number	434897
Medical Device Problem Codes	Failure to Deliver (2338); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A pk papyrus covered stent system was selected for treatment of a type iii perforation in the main branch of the rca.The device got stuck on shaft of delivery catheter.The device was removed from patients body.Another pk papyrus was implanted and the perforation was successfully sealed.
Additional Manufacturer Narrative
The returned product was subjected to a technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned instrument revealed that the balloon is well folded and shows no signs of inflation.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the bent struts were initially crimped on the balloon.The stent was returned separately and is severely deformed over its entire length.The returned guideliner was identified as a 6f guideliner guiding extension catheter with an inner diameter of 1.42 mm.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of the final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent and the stent retention force of a defined amount of samples is tested from every lot.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the extension catheter whose dimensions do not meet the requirements specified in the pk papyrus ifu.It should be noted that 4.5 mm and 5.0 mm pk papyrus require larger minimum inner diameter of guiding and extension catheters than smaller pk papyrus sizes.

• 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
• MDR Report Key: 12474121
• Report Number: 1028232-2021-05117
• Device Sequence Number: 19681173
• Product Code: NIV
• UDI-Device Identifier: 07640130447257
• UDI-Public: 07640130447257
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 434897
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03211126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization