MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.75/18; CORONARY DRUG-ELUTING STENT

Model Number	364489
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Ous mdr - the drug eluting stent system orsiro was chosen for the intervention.The stent dislodged from the balloon outside of the patient's body during preparation.No further information is available at this time.
Additional Manufacturer Narrative
The technical investigation revealed that the orsiro stent is marginally deformed and displaced in distal direction.Microscopic analysis of the balloon surface revealed clear visible stent imprints, indicating that the stent was properly crimped in between the two radiopaque markers at the time of delivery.The balloon is well folded and shows no signs of inflation.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The final root cause is most likely related to external factors during the preparations for the intervention.

• Brand Name: ORSIRO 2.75/18
• 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: 8480715
• Report Number: 1028232-2019-01342
• Device Sequence Number: 13766569
• Product Code: NIQ
• UDI-Device Identifier: 07640130439047
• UDI-Public: 7640130439047
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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 Model Number: 364489
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08182847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1