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

Model Number 364514

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro drug-eluting stent system was implanted in a pre-dilated severely calcified lesion (100 percent stenosis degree) in the moderately tortuous rca.After the intervention the patients condition became worse.During additional angiography it was noticed that the complaint stent was occluded.Aspiration was done but could not eliminate all occlusion, therefore another orsiro was implanted.

Manufacturer Narrative

Combination product: yes shortly after treating a prox.Rca lesion with a orsiro 3.0/30 des the patient status became worse.Examination revealed a stent thrombosis at the level of the implanted des.The treatment was finished with the successful placement of another orsiro des.The device itself was not returned to biotronik and could therefore not be subjected to a technical investigation.However, the provided report was reviewed.Further the production documentation of the product was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.Review of the production documentation for the product described above confirmed that the device was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the reviewed documentation and the conducted investigation no device deficiency or manufacturing related root cause could be identified.

• Brand Name: ORSIRO 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: 11770526
• MDR Text Key: 248830502
• Report Number: 1028232-2021-02272
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2022
• Device Model Number: 364514
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03204057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1