MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/22; CORONARY DRUG-ELUTING STENT

Model Number 364500

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Event Description

The orsiro drug-eluting stent system was selected for use.After pre-dilatation it was intended to implant the orsiro in the medial lad but eventually it was implanted in the proximal lad.

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 balloon is well folded and shows no signs of inflation.Stent imprints are visible on the balloon surface, indicating that the stent was initially crimped centered on the balloon.A small amount of dried contrast medium residue was observed in the inflation lumen which implies application of vacuum with the inflation device.The stent was implanted and therefore not returned for analysis.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 and the stent retention force of a defined amount of samples is tested from every lot.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the procedure (i.E.Application of vacuum).

• Brand Name: ORSIRO 2.5/22
• 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: 9396375
• MDR Text Key: 168657383
• Report Number: 1028232-2019-05285
• 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: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 364500
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01190411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1