MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/40; CORONARY DRUG-ELUTING STENT

Model Number 391239

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Event Description

The orsiro drug-eluting stent system was chosen for the treatment of a calcified and tortuous lesion in the mid lad.The target lesion could not be crossed.

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.Furthermore the provided angiographic material was reviewed.The technical investigation of the returned instrument revealed that the stent is deformed at its distal end, several struts are bent.Outside of the deformed zone the crimped stent diameter still complies with the specification.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the bent struts were initially crimped on the balloon.The balloon is well folded and shows no signs of inflation.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.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 the final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO 2.5/40
• 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: 9633041
• MDR Text Key: 176476483
• Report Number: 1028232-2020-00421
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439429
• UDI-Public: 07640130439429
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: 391239
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05193520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1