MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/26; CORONARY DRUG-ELUTING STENT

Model Number	364506
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
An orsiro drug-eluting sent system was chosen for treatment.During unpacking it was detected that the stent was dislodged.The device was not used.
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 the stent severely deformed and elongated at its distal end.Microscopic analysis revealed stent imprints on the exposed balloon surface, indicating that the deformed struts were initially crimped on the balloon.Dried contrast medium was found in the inflation lumen as well as in the balloon lumen up to the position of the deformation.The stent protector was not returned for analysis.A reference protector cap could not be slid over the deformed struts without bending them further.Since it was not possible to apply a reference protector cap over the deformed struts without bending them further, it can be excluded beyond reasonable doubt that the damage was already present on delivery of the instrument.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.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 complaint event is most likely related to the handling during the preparation for the intervention (i.E.Application of negative pressure prior to the placement across the target lesion), which is warned against in the ifu.

• Brand Name: ORSIRO 2.5/26
• 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: 10202687
• Report Number: 1028232-2020-02619
• Device Sequence Number: 14011722
• Product Code: NIQ
• UDI-Device Identifier: 07640130439153
• UDI-Public: 7640130439153
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/25/2020

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: 06/24/2021
• Device Model Number: 364506
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06190596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1