MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/40; CORONARY DRUG-ELUTING STENT

Model Number 391020

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Event Description

Ous mdr - an orsiro drug-eluting stent system was selected for use.During stent positioning backflow of blood was observed.Therefore the device was removed from the patient's body and another device was used for the procedure.

Event Description

Ous mdr an orsiro drug-eluting stent system was selected for use.During stent positioning backflow of blood was observed.Therefore the device was removed from the body and another device was used for the procedure.

Manufacturer Narrative

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 this event.The technical investigation of the returned orsiro revealed that the balloon is well folded and shows no signs of inflation.The stent is crimped between the x-ray markers.During microscopic analysis no leakage or damage was detected.Due to dried residue the complaint device could not be inflated even after immersing into decontamination liquid for three days.The device is clogged and therefore a leakage could not be identified.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 each instrument is tested for air tightness by means of a helium leak test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, no manufacturing or material related root cause was determined.

• Brand Name: ORSIRO 3.5/40
• 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: 8515115
• MDR Text Key: 141959603
• Report Number: 1028232-2019-01484
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439450
• UDI-Public: 07640130439450
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2020
• Device Model Number: 391020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07182876
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization