MAUDE Adverse Event Report: BIOTRONIK AG PRO-KINETIC ENERGY 3.0/15; BARE-METAL CORONARY ARTERY STENT

Model Number	383877
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the stent could not pass the lesion.
Additional Manufacturer Narrative
The returned instrument was 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 the reported event.The technical investigation of the returned device showed that the stent is still crimped in between the two x-ray markers.The crimped stent diameter was measured and is still within the specification.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material- or manufacturing related root cause was determined.The reported of difficulties in lesion crossing is most likely related to the patients anatomy.

• Brand Name: PRO-KINETIC ENERGY 3.0/15
• Common Device Name: BARE-METAL CORONARY ARTERY STENT
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• MDR Report Key: 7846115
• Report Number: 1028232-2018-03030
• Device Sequence Number: 1143832
• Product Code: MAF
• UDI-Device Identifier: 07640130434981
• UDI-Public: (01)07640130434981
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P160003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2018

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: 01/23/2020
• Device Model Number: 383877
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01171203
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1