MAUDE Adverse Event Report: BIOTRONIK AG PRO-KINETIC ENERGY 5.0/15; BARE-METAL CORONARY ARTERY STENT

Model Number 371460

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2017

Event Type  malfunction  

Event Description

The pke stent balloon did not inflate.Pke stent system was removed and another pke stent system was used to successfully close the procedure.

Manufacturer Narrative

The balloon was still folded and showed no signs of inflation at the time the device was returned for investigation.Microscopic investigation of the gep revealed that the guide wire lumen and the inflation lumen are sliced open.Therefore, the stent could not be inflated.The described observation was most probably induced by the guide wire during the procedure.The leakage of the inflation lumen is presumably a direct consequence of the guide wire exit port lying outside of the guiding catheter which is warned against in the ifu.Further the device was used against the indication outlined in the ifu.A 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.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was manufactured according to specification and delivered in a leak proof condition.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: PRO-KINETIC ENERGY 5.0/15
• Type of Device: BARE-METAL CORONARY ARTERY STENT
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; buelach CH-81 80; SZ CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6463735
• MDR Text Key: 72124798
• Report Number: 1028232-2017-01179
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P160003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

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
• Device Operator: Health Professional
• Device Model Number: 371460
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11155851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1