MAUDE Adverse Event Report: BIOTRONIK AG PULSAR-18 4/100/135; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number 366828

Device Problem Difficult to Remove (1528)

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

Event Date 03/12/2018

Event Type  malfunction  

Event Description

Ous mdr - after release it was noticed that the end of the shaft was caught inside the stent struts.

Manufacturer Narrative

A technical analysis of the returned instrument was conducted and a review of the manufacturing history was performed to evaluate whether there was any deviation that could account for the reported event.The technical investigation of the returned device revealed that the stent was successfully released in the moderate tortuous anatomy, according to ifu using the secondary release mechanism.The further evaluation showed a minor deformation at the proximal end of the tip which most probably occurred during withdrawal of the stent system through the released stent.Review of the production documentation verified that the instrument detailed above was manufactured according to specifications.The device fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint no manufacturing or material related root cause could be determined.Since the manufacturing history does not show any indication of a problem with the device and since the stent was successfully released, it seems likely that the root cause for the complaint event is related to external factors during the procedure.

• Brand Name: PULSAR-18 4/100/135
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 7483706
• MDR Text Key: 107329361
• Report Number: 1028232-2018-01492
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P160025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 366828
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06172488
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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