MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/35; CORONARY DRUG-ELUTING STENT

Model Number 391235

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Event Description

Ous mdr - the orsiro drug-eluting stent system was selected for use.A device leakage was observed before balloon inflation.True lot number is unknown.

Manufacturer Narrative

The returned instrument was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned orsiro revealed that both the inflation lumen and the guide wire lumen were found to be sliced open.This damage patter occurs when the guide wire exit port was lying outside of the guiding catheter, making it possible to spread apart the guide wire and the instrument.The review of the production documentation of 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 of the device being subject to this complaint, no manufacturing or material related root cause was determined.The final root cause for the leakage is most likely related to handling of the device during procedure.

• Brand Name: ORSIRO 2.5/35
• 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: 8506556
• MDR Text Key: 141730300
• Report Number: 1028232-2019-01386
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439368
• UDI-Public: 07640130439368
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 391235
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07185291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/11/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1