MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/40; CORONARY DRUG-ELUTING STENT

Model Number	391020
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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.The device could not cross the mild calcified lesion (90 percent stenosis degree) in the severe tortuous distal lad and the stent was deformed.
Additional Manufacturer Narrative
Combination product: yes.The returned device was subjected to a detailed 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 stent and balloon show no irregularities.A stent deformation could not be confirmed, the crimped stent diameter is in specification.The review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.As a part of final inspection every stent system undergoes visual inspection to ensure correct 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 could be determined.It should be noted that the ifu clearly states that a predilatation of the target lesion is mandatory.

• Brand Name: ORSIRO 3.5/40
• 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: 11732775
• Report Number: 1028232-2021-02105
• Device Sequence Number: 14459727
• Product Code: NIQ
• UDI-Device Identifier: 07640130439450
• UDI-Public: 07640130439450
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 05/02/2021
• Device Model Number: 391020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04192880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1