MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.25/22; CORONARY DRUG-ELUTING STENT

Model Number	401753
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.Upon removal of the stylet a deformation was detected.
Additional Manufacturer Narrative
Combination product: yes the returned product 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 this event.The technical investigation revealed that the stent is severely deformed at its proximal end, i.E.Several struts are bent.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the deformed struts were initially crimped on the balloon.The balloon is well folded and shows no signs of inflation.A reference stent protector could not be slid over the deformed struts without bending them further.It can therefore be excluded beyond reasonable doubt that the damage was already present on delivery of the instrument.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 (US) 2.25/22
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 11467108
• Report Number: 1028232-2021-01184
• Device Sequence Number: 3522881
• Product Code: NIQ
• UDI-Device Identifier: 07640130439085
• UDI-Public: 07640130439085
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2021
• Device Model Number: 401753
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10191171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1