MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/15; CORONARY DRUG-ELUTING STENT SYSTEM

Model Number 364482

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2020

Event Type  malfunction  

Event Description

An orsiro drug-eluting stent system was selected for treatment of a moderately calcified lesion (75 percent stenosis degree) in a severely tortuous lad.After predilatation it was tried to cross the lesion with the orsiro but after several attempts the shaft broke.Therefore the system was removed from the patients body.

Manufacturer Narrative

Combination product: yes.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 the reported event.The technical investigation of the returned device revealed that the hypotube has fractured about 19cm distal to the distal end of the kink protector.Kinks were observed close to the fracture sites of both fragments.The cross sections of the hypotube are no longer circular, but compressed and the polymer coating is plastically deformed.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of the patients body.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all inprocess and final inspections.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 of the device.It should be noted that the ifu warns the user against reinsertion.

• Brand Name: ORSIRO 2.5/15
• Type of Device: CORONARY DRUG-ELUTING STENT SYSTEM
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 10422809
• MDR Text Key: 203449730
• Report Number: 1028232-2020-03465
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 364482
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01191529
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1