MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/18; CORONARY DRUG-ELUTING STENT

Model Number 419120

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

An orsiro mission drug-eluting stent system was selected for treatment of a pre-dilated severely calcified lesion in a distal severely tortuous rca.During advancing the device resistance was felt.In the angiographic film an elongation of the stent was observed.The stent was adapted to the vessel wall proximal to the lesion.Another stent was used to complete the intervention.

Manufacturer Narrative

Combination product: yes the returned instrument was subjected to a 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.In addition, five pictures taken from the angiographic material were reviewed.The technical investigation of the returned instrument revealed that the balloon is not well folded anymore and shows signs of inflation.Microscopic analysis of the exposed balloon surface revealed stent imprints, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The stent was not returned for analysis.The pictures taken from the angiographic material show the target lesion in the distal rca as well as the complaint instrument being positioned in the proximal rca.The actual complaint event is not visible.Review of the angiographic material did therefore not lead to any further information regarding the nature of the complaint.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent.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 2.5/18
• 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: 11037672
• MDR Text Key: 222340624
• Report Number: 1028232-2020-05547
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 12/16/2020

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: 07/20/2022
• Device Model Number: 419120
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06203576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1