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

Model Number	401747
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro us drug-eluting stent system was selected to treat a lesion in the distal lcx.After successful stent deployment it was difficult to remove the orsiro us delivery balloon.
Additional Manufacturer Narrative
The returned instrument 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 the reported event.In addition, the angiographic material provided was reviewed.The technical investigation of the returned product revealed that the balloon has been inflated and was deflated in the as-returned state.The balloon was inspected under the microscope and shows no damage or irregularity.Microscopic inspection of the guidewire exit port revealed that both the guidewire lumen and the inflation lumen are severely damaged and sliced open longitudinally over a length of about 93 mm.The slicing originates at the proximal part of the guidewire exit port and was most likely induced by the guidewire after successful balloon inflation.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The actual complaint event is not visible.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The damage at the guidewire exit port is most likely related to the handling during the procedure.It should be noted that the ifu advises the user to exercise care during device handling to reduce the possibility of accidental breakage, bending, kinking of the stent system shaft.

• Brand Name: ORSIRO (US) 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
• MDR Report Key: 10159164
• Report Number: 1028232-2020-02457
• Device Sequence Number: 11695361
• Product Code: NIQ
• UDI-Device Identifier: 07640130439023
• UDI-Public: 07640130439023
• Combination Product (Y/N): N
• 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): 05/26/2020

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: 04/10/2021
• Device Model Number: 401747
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04190152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization