MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/18; CORONARY DRUG-ELUTING STENT

Model Number 401751

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Event Description

An orsio drug-eluting stents system was selected for treatment of the rca.During procedure the hypotube fractured approx.5 inches from proximal end.

Manufacturer Narrative

Only the distal fragment of the instrument was returned.The returned device fragment 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 fragment revealed that the hypotube is kinked at several locations and has fractured about 108 cm proximal to the distal end of the device.The cross-section of the hypotube is no longer circular, but compressed and the polymer coating is plastically deformed.This indicates that the hypotube most probably fractured as a result of significant bending outside the patients body.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process 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.

• Brand Name: ORSIRO (US) 3.5/18
• 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: 9949275
• MDR Text Key: 187256249
• Report Number: 1028232-2020-01659
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439061
• UDI-Public: 07640130439061
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

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: 07/08/2021
• Device Model Number: 401751
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06193108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR