MAUDE Adverse Event Report: BIOTRONIK AG PRO-KINETIC ENERGY 4.0/35; BARE-METAL CORONARY ARTERY STENT

Model Number 383908

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2017

Event Type  malfunction  

Event Description

We were notified that this stent got entrapped on calcium when trying to unsheathe it.The stent will be returned.The patient is an (b)(6) year old male.

Manufacturer Narrative

The returned product 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 this event.Microscopic analysis of the returned delivery system revealed clearly visible stent embedding traces on the balloon surface, indicating that the stent was properly crimped between the two x-ray markers at the time of delivery.Review of the manufacturing history of the product detailed above did not reveal any non-conformity.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.The device in question was manufactured according to specifications and successfully passed all in-process controls as well as the final inspection.Based on the conducted investigations no material or manufacturing related root cause could be determined.The final root cause for the stent dislodgement is most likely related to external factors during intervention.Further, the stent was used in the posterior tibial artery against the ifu.

• Brand Name: PRO-KINETIC ENERGY 4.0/35
• 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: 6551266
• MDR Text Key: 74630403
• Report Number: 1028232-2017-01497
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/28/2017

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: 383908
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08165109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2016
• 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