MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/22; CORONARY DRUG-ELUTING STENT

Model Number 401754

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Restenosis (4576)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

(b)(6) study: after nstemi, treatment with 2 orsiro drug-eluting stent systems was performed in 2016.On (b)(6) 2020 patient experienced chest pain and nstemi.Medication was given.A restenosis was detected, treated with balloon angioplasty and a new des stent.

Manufacturer Narrative

Combination product: yes neither the complaint instrument nor the angiographic material was provided for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations no manufacturing related root cause could be identified.

• Brand Name: ORSIRO (US) 2.5/22
• 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: 11422373
• MDR Text Key: 234951759
• Report Number: 1028232-2021-01068
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439092
• UDI-Public: 07640130439092
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

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 Model Number: 401754
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 65154865
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization