MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND PULSAR-18 6/170/90; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366821

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Event Description

The pulsar 18 stent system was selected for use.During deployment the stent did not deploy properly.However it was completely released but curled up a little bit.

Manufacturer Narrative

The complaint instrument was not returned for analysis.Therefore no technical investigation on the device could be performed.The corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.Further, the provided angiographic material was reviewed.The provided angiographic material shows the target lesion before and after the implantation of the complaint stent; geometric distortions of the stent structure are visible.The inhomogeneous radiopacity along the stent length may be suggestive of stent elongation.However, the actual complaint event is not visible.Review of the production documentation of the product detailed above confirmed that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no manufacturing or material related root cause could be determined.The final root cause is most likely related to handling issues during stent release.

• Brand Name: PULSAR-18 6/170/90
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 8962549
• MDR Text Key: 156575195
• Report Number: 1028232-2019-03840
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 366821
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03187211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1