MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/40; CORONARY DRUG-ELUTING STENT

Model Number 391021

Device Problem Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

The orsiro drug-eluting stent system was chosen for the treatment of a calcified lesion in the lad.After pre-dilatation the orsiro was delivered to the target lesion but a stent deformation was noted during positioning.Thus the orsiro was replaced with another stent and the procedure was finished.

Manufacturer Narrative

The returned product was subjected to a 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 instrument revealed that the stent is severely deformed at its proximal end.Several stent struts are bent outwards.The stent has dislodged but it could be clarified that the stent was separated from its delivery system by the hospital staff after successful withdrawal of the instrument.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that all struts were initially crimped on the balloon.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO 4.0/40
• 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: 10311723
• MDR Text Key: 199979400
• Report Number: 1028232-2020-03022
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2020
• Device Model Number: 391021
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09184472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1