MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.5/13; CORONARY DRUG-ELUTING STENT

Model Number	401739
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro us drug eluting stent system was selected for use.Upon inspection of the delivery system for reinsertion it was detected that the stent was displaced distally.The stent was initially delivered through a guideliner.
Additional Manufacturer Narrative
The returned product was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the returned instrument revealed that two stent struts are bent outwards at the distal end of the stent.Judging from the x-ray markers the stent is neither displaced nor dislodged.Microscopic analysis revealed stent imprints on the exposed balloon surface indicating that the bent struts were initially crimped on the balloon.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.Further, the stent outer diameter is verified to 100 percent and the stent retention force of a defined amount of samples is tested from every lot.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 or material related root cause could be determined.The final root cause is most likely related to unknown external factors during the procedure.It should be noted that according to the ifu pre-dilatation of the target lesion is mandatory and the product should not to be re-inserted.

• Brand Name: ORSIRO (US) 3.5/13
• 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: 8982333
• Report Number: 1028232-2019-03885
• Device Sequence Number: 2891913
• Product Code: NIQ
• UDI-Device Identifier: 07640130438941
• UDI-Public: 07640130438941
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 10/15/2020
• Device Model Number: 401739
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 09184615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1