MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 2.75/18; CORONARY DRUG-ELUTING STENT

Model Number 453945

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem Vascular Dissection (3160)

Event Date 12/20/2021

Event Type  Injury  

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a lesion with 99 percent stenosis degree in the cx.After post-dilatation of the orsiro mission stent with an nc balloon and further preparation of another distal lesion, the balloon got stuck at the distal end of the implanted stent.During withdrawal of the balloon, the previously implanted stent became deformed, migrated and was finally adapted to the vessel wall.Additionally, there was a non-flow-limiting dissection which was treated with a des.Finally, the patient was stable and was discharged home.

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 product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: ORSIRO MISSION (US) 2.75/18
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13236397
• MDR Text Key: 283673531
• Report Number: 1028232-2022-00151
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130456013
• UDI-Public: 07640130456013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2023
• Device Model Number: 453945
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06214847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female