MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 3.0/30; CORONARY DRUG-ELUTING STENT

Model Number 419140

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

An orsiro mission drug-eluting stent system was selected for treatment.During preparation it was very difficult to advance the orsiro mission stent on the sion blue guidewire.Therefore, the device was not used in patient.

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 orsiro mission revealed that the guidewire lumen is slightly clogged with dried blood at its proximal end.After dissolving these blood clots with clean water, a 0.014 inch reference guidewire and a 0.015 inch transportation wire could be completely introduced from distal without noticeable friction.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.The device has been delivered with a 0.015 inch transportation wire and no difficulties in removing this wire have been reported.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO MISSION 3.0/30
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9588584
• MDR Text Key: 174959080
• Report Number: 1028232-2020-00205
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P170030
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2020
• Device Model Number: 419140
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09196894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1