MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/18; CORONARY DRUG-ELUTING STENT

Model Number 401748

Device Problem Use of Device Problem (1670)

Patient Problem Vascular Dissection (3160)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro us drug-eluting stent system was selected for treatment.A dissection has occurred at the edge of the stent in the proximal lad.The dissection was covered by placing a second 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.It should be noted that, according to the physician, the orsiro us was properly deployed and the perforation was successfully sealed with the second orsiro.The stent information worksheet clearly states that there was no malfunction with the complaint device.It further should be noted that the ifu clearly states that the balloon pressure should not exceed the rated burst pressure (rbp).

• Brand Name: ORSIRO (US) 2.5/18
• 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: 10818100
• MDR Text Key: 215573030
• Report Number: 1028232-2020-04880
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439030
• UDI-Public: 07640130439030
• 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,user f
• 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: 08/29/2021
• Device Model Number: 401748
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08191253
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization