MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/18; CORONARY DRUG-ELUTING STENT

Model Number 364487

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

Ous mdr - it was intended to treat a coronary total occlusion (cto) in a tortuous left coronary vessel.During the procedure the stent dislodged and was finally adapted to the vessel wall with another balloon.It should be noted that, according to the ifu, the safety and effectiveness of orsiro have not yet been established in patients with cto.The hospitalization was prolonged 3 days.The physician wanted to monitor flow rates and adjust the medical dose.

Manufacturer Narrative

The device was not returned to biotronik.Therefore no technical investigation on the subject could be performed.The manufacturing history was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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 manufacturing related root cause was determined.The final root cause for the reported event could not be identified.

• Brand Name: ORSIRO 2.25/18
• 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: 8480707
• MDR Text Key: 140876321
• Report Number: 1028232-2019-01345
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439023
• UDI-Public: 7640130439023
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2020
• Device Model Number: 364487
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07181501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization