MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.5/22; CORONARY DRUG-ELUTING STENT

Model Number	453953
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro mission drug-eluting stent system was selected for treatment.The device was placed down in a vein graft and inflated to nominal pressure, but the balloon would not inflate due to a pin hole at distal end of balloon.
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.The technical investigation revealed that the proximal balloon shoulder is slightly unfolded, and blood was found inside of the inflation lumen and the balloon lumen.The stent is still crimped on the balloon between the x-ray markers and the crimped diameter is still in specification.The distal balloon shoulder shows a damage in the shape of a small cut.This cut is reaching through the wall of the balloon shoulder, causing a leakage.The leakage of the balloon most likely contributed to the inability to expand the stent.However, the cause of the damage of the balloon shoulder could not be clarified.Review of the product release documentation verified that the instrument detailed above was manufactured according to specifications.The device fulfilled all the requirements of in-process and final inspection.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leak test.The instrument was delivered in a leak-proof condition.Based on the conducted investigations no material or manufacturing related root cause could be identified.

• Brand Name: ORSIRO MISSION (US) 3.5/22
• 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: 13367508
• Report Number: 1028232-2022-00471
• Device Sequence Number: 3743776
• Product Code: NIQ
• UDI-Device Identifier: 07640130456099
• UDI-Public: 07640130456099
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 10/08/2023
• Device Model Number: 453953
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09212410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2021
• 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