MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.5/9; CORONARY DRUG-ELUTING STENT

Model Number	401730
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 it was intended to place the orsiro drug-eluting stent in the distal rca.On the next day it was noticed that the stent had dislodged from the balloon prior to deployment and only a poba was performed.Eventually the stent migrated to the plv and remained in the patients body.
Additional Manufacturer Narrative
The device was not returned for technical investigation.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 of the reported event.In addition, the angiographic material provided was reviewed.Review of the production 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% and the stent retention force of a defined amount of samples is tested from every lot.The angiographic material provided contains no further information relevant for clarification of the complaint event.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.The root cause is most likely related to external factors during the intervention.It should be noted that the ifu warns against re-insertion.

• Brand Name: ORSIRO (US) 2.5/9
• 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: 9158975
• Report Number: 1028232-2019-04351
• Device Sequence Number: 14117578
• Product Code: NIQ
• UDI-Device Identifier: 07640130438859
• UDI-Public: 07640130438859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/20/2019

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: 11/18/2020
• Device Model Number: 401730
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11180804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1