MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/18; CORONARY DRUG-ELUTING STENT

Model Number	364487
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug eluting stent system was selected for treatment of a severely calcified lesion (90 percent stenosis degree).The orsiro stent system could not cross the lesion in the severe tortuous diagonal.Another stent was used to complete the intervention.
Additional Manufacturer Narrative
The returned device was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, the angiographic material provided was reviewed.The technical investigation revealed that the stent is deformed at its distal end, i.E.Few struts are bent.Microscopic inspection showed 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, but contrast medium residue was observed in the inflation lumen which indicates application of negative pressure.The angiographic material shows the implantation a stent in the target vessel.Thereafter, an unsuccessful attempt of crossing the proximal portion of the previously implanted stent with the complaint instrument is visible.After withdrawal of the complaint instrument, a shorter stent is successfully implanted.It remains unclear if the complaint stent was deformed prior to or during the crossing attempt.The angiographic material does therefore not provide any further relevant information with regards to the root cause of the complaint.Review of the product release documentation confirmed that the device 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 and the stent retention force of a defined number of samples is tested from every lot.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.

• Brand Name: ORSIRO 2.25/18
• Common Device Name: 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: 13167960
• Report Number: 1028232-2022-00034
• Device Sequence Number: 14786072
• Product Code: NIQ
• UDI-Device Identifier: 07640130439023
• UDI-Public: 7640130439023
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 05/11/2023
• Device Model Number: 364487
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04211310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown