MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/22; CORONARY DRUG-ELUTING STENT

Model Number	401756
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting stent system was chosen to treat a calcified pre-dilated lesion (99 percent stenosis degree) in tortuous om.The device could not cross the lesion.During withdrawal the stent dislodged and was adapted to the vessel wall with another stent.
Additional Manufacturer Narrative
12-sep-2019: during an internal audit, it was found that the description from this report was incorrect.Per rep, this device was no cross only, stent was removed and smaller diameter inserted.Updating report.Neither the complaint instrument nor the angiographic material was provided for analysis.Therefore no technical investigation on the subject could be performed.The manufacturing history was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the manufacturing history of the product detailed above did not reveal any non-conformity.The device in question was manufactured according to specifications and successfully passed all inprocess controls as well as the final inspection.Based on the conducted investigations no manufacturing related root cause could be determined.The root cause is most likely related to external factors during the procedure.

• Brand Name: ORSIRO (US) 3.0/22
• 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: 8897357
• Report Number: 1028232-2019-03508
• Device Sequence Number: 13535371
• Product Code: NIQ
• UDI-Device Identifier: 07640130439115
• UDI-Public: 07640130439115
• 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): 07/31/2019

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 Expiration Date: 11/12/2020
• Device Model Number: 401756
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10186667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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