MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PK PAPYRUS US 3.0/20; COVERED CORONARY STENT

Model Number	434894
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An pk papyrus covered stent system was selected to treat a perforation in the lad.As it was tried to deploy the stent it dislodged from the balloon.Therefore the dislodged stent was retrieved by using a snare.
Additional Manufacturer Narrative
The returned stent and the returned device were subjected to a technical analysis and the corresponding production 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 device revealed that the balloon is not well folded anymore and shows clear signs of inflation.Microscopic analysis of the balloon surface revealed clear visible stent imprints, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent is severely deformed over its entire length.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.During final inspection, every stent system undergoes visual inspection to ensure correct stent 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 of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PK PAPYRUS US 3.0/20
• 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: 9317590
• Report Number: 1028232-2019-05030
• Device Sequence Number: 380573
• Product Code: NIV
• UDI-Device Identifier: 07640130447226
• UDI-Public: 07640130447226
• 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): 10/28/2019

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: 02/28/2021
• Device Model Number: 434894
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 02192475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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