MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/30; CORONARY DRUG-ELUTING STENT

Model Number	401766
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.Stent came off the wire with the removal of the stent protective cover before insertion.The stent fell outside of the sterile field.
Additional Manufacturer Narrative
Combination product: yes.
Additional Manufacturer Narrative
Combination product: yes only the stent was returned and subjected to a technical investigation.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The stent was returned unprotected in a plastic bag.The stent is deformed (i.E.Kinked twice) in its center.Both the delivery system and the stent protector were not returned for analysis.Review of the product release 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 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.

• Brand Name: ORSIRO (US) 2.5/30
• 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: 15679508
• Report Number: 1028232-2022-05485
• Device Sequence Number: 12252365
• Product Code: NIQ
• UDI-Device Identifier: 07640130439214
• UDI-Public: (01)07640130439214(17)2308
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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: 08/10/2023
• Device Model Number: 401766
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07210327
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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