MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/35; CORONARY DRUG-ELUTING STENT

Model Number 391018

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

The orsiro drug-eluting stent system was selected for use.After pre-dilatation and stent deployment the deflation time of the balloon took longer than usual, approximately 10 seconds.

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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 reported event is most likely related to the handling during the procedure (i.E.Insufficient deflation time).It should be noted that the ifu clearly states that the instrument shall be deflated for at least 35 seconds.

• Brand Name: ORSIRO 3.5/35
• 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: 10311729
• MDR Text Key: 199978737
• Report Number: 1028232-2020-03028
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439399
• UDI-Public: 07640130439399
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: 391018
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11180475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1