MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/18; CORONARY DRUG-ELUTING STENT

Model Number 364487

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2019

Event Type  malfunction  

Event Description

An orsiro drug-eluting stent system was chosen for treatment.During post dilatation the stent got stuck on the balloon and got displaced.

Manufacturer Narrative

The complaint device was not returned to biotronik for analysis.The manufacturing history was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.In addition, the provided angiographic material was reviewed.The angiographic material showed the treatment but the complaint event is not visible.It did not reveal any further conclusion on the root cause of the reported event.Review of the manufacturing history of the product detailed above did not reveal any non-conformity.During final inspection, every stent system undergoes visual inspection to ensure correct stent 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.The device in question was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.However, it seems likely that the root cause for the complaint event is related to external factors during the procedure.

• Brand Name: ORSIRO 2.25/18
• 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: 8888686
• MDR Text Key: 154151287
• Report Number: 1028232-2019-03433
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439023
• UDI-Public: 7640130439023
• 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: 08/12/2019

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 Expiration Date: 08/12/2019
• Device Model Number: 364487
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08183580
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization