MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PRO-KINETIC ENERGY US 2.75/18; STENT, CORONARY

Model Number	383883
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product was not returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted review, no manufacturing related root cause could be identified.The pro-kinetic energy (us) was used after the use by date which is indicated on the product label and warned against in the ifu.It was confirmed that the use by date was not checked prior to the device introduction.
Event or Problem Description
A pro-kinetic energy was placed on (b)(6) 2024 in an unknown vessel (no lesion details were provided) and discovered later that the expiration on the device was 13-october-2023.It was successfully implanted 171 days (5 months, 2 weeks, 5 days) after the expiry date.The patient still has the stent and has no problems.
Additional Manufacturer Narrative
Corrected the initial reporter information.Reference capa# nc-24-004.The affected product was not returned.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted review, no manufacturing related root cause could be identified.The pro-kinetic energy (us) was used after the use by date which is indicated on the product label and warned against in the ifu.It was confirmed that the use by date was not checked prior to the device introduction.

• Brand Name: PRO-KINETIC ENERGY US 2.75/18
• Common Device Name: STENT, CORONARY
• 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: 19689986
• Report Number: 1028232-2024-03589
• Device Sequence Number: 12769398
• Product Code: MAF
• UDI-Device Identifier: 07640130435049
• UDI-Public: (01)07640130435049(17)2310
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 10/13/2023
• Device Model Number: 383883
• Device Catalogue Number: 383883
• Device Lot Number: 10201292
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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 Age: 75 YR
• Patient Sex: Male