MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/26; CORONARY DRUG-ELUTING STENT

Model Number 364509

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2019

Event Type  malfunction  

Event Description

An orsiro drug-eluting stent system was selected to treat a calcified lesion in a tortuous proximal lad.After deployment of the stent the wire looped and got caught on stent struts when pulling back whereby the stent became deformed.

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was provided 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 in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.It should be noted that the ifu warns to exercise care when crossing a newly deployed stent with a coronary guidewire.

• Brand Name: ORSIRO 3.5/26
• 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: 9315257
• MDR Text Key: 166627699
• Report Number: 1028232-2019-05014
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Model Number: 364509
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07185326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization