MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/26; CORONARY DRUG-ELUTING STENT

Model Number	364508
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug eluting stent system was selected for treatment of the moderate calcified lesion in a moderate tortuous rca.Despite pre-dilatation the lesion could not be crossed with the device due vessel tortuosity.The stent was deformed.
Event or Problem Description
An orsiro drug eluting stent system was selected for treatment of the moderate calcified lesion in a moderate tortuous rca.Despite pre-dilatation the lesion could not be crossed with the device due to vessel tortuosity.The stent was deformed.
Additional Manufacturer Narrative
The returned product 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 the reported event.In addition, the angiographic material provided was reviewed.The technical investigation revealed that the stent is slightly deformed at its distal end, i.E.Few struts are lifted.Microscopic inspection showed stent imprints on the exposed balloon surface, indicating that the bent struts were initially crimped on the balloon.The balloon is well folded and shows no signs of inflation.The angiographic material shows a balloon dilation in the mid rca, followed by the implantation of a stent and several balloon dilations in the proximal rca.Thereafter, the complaint instrument is introduced but cannot be advanced through the proximal rca.The stent system is withdrawn to perform another balloon dilatation.The stent system is then re-introduced but again fails to cross the proximal rca segment.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in process and final inspections.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 and the stent retention force of a defined amount 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 was determined.The root cause for the complaint event is most likely related to the patients anatomy.

• Brand Name: ORSIRO 3.0/26
• 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: 12721031
• Report Number: 1028232-2021-05921
• Device Sequence Number: 6713557
• Product Code: NIQ
• UDI-Device Identifier: 07640130439177
• UDI-Public: 7640130439177
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 07/15/2022
• Device Model Number: 364508
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06202420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2020
• 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