MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/22; CORONARY DRUG-ELUTING STENT

Model Number 364502

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis (2100)

Event Date 07/09/2019

Event Type  malfunction  

Event Description

40 days after primary intervention the patient returned to the hospital and a control angio revealed a stent thrombosis.

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.The provided angiographic material was reviewed by a medical affairs expert.The images of the baseline procedure show the pre-dilatation of the target lesion as well as the implantation and post-dilatation of the complaint stent.In the angiographic material of the follow-up procedure the occluded proximal part of the complaint stent is visible.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations no manufacturing related root cause was determined.

• Brand Name: ORSIRO 3.0/22
• 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: 8827408
• MDR Text Key: 152234725
• Report Number: 1028232-2019-03113
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Model Number: 364502
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11183423
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention