MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/26; CORONARY DRUG-ELUTING STENT

Model Number 401763

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro us drug-eluting stent system was selected for treatment.The proximal lad was uneventful and successfully stented with the orsiro us stent.There was an abrupt closure of a 2mm diagonal vessel with stent implantation, which resulted in some chest discomfort and minimal st elevation in the lateral leads.This was expected to be temporary with expected return of flow.After procedure patient experienced chest pain.A stent thrombosis was detected approx 2 hours after implantation.

Manufacturer Narrative

Combination product: yes.Neither the complaint instrument nor the angiographic material was available 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 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.However, it is noted that the patient vomited within the first two hours of recovery, although no pills were noted in the emesis, according to nursing.This may have been weakened the antiplatelet therapy.

• Brand Name: ORSIRO (US) 3.5/26
• 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: 10818103
• MDR Text Key: 215573056
• Report Number: 1028232-2020-04881
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439184
• UDI-Public: 07640130439184
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: 401763
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05194426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization