MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/40; CORONARY DRUG-ELUTING STENT

Model Number	391239
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment.While removing the stent protector, the stent was attached to the protector and was pulled out with it.Another stent was used.
Additional Manufacturer Narrative
Combination product: yes.Only the stent was returned for investigation and subjected to a technical analysis.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In the as-returned state the stent was located on the transportation wire inside the stent protector.The stent is slightly deformed at its proximal end, i.E.It is pinched and few struts are bent.At the proximal end of the stent and the stent protector dried contrast medium residue was found.The delivery system was not available for analysis.Review of the product release 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.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 for the complaint event is most likely related to the handling during the preparations for the intervention.It should be noted that the ifu instructs the user to pull at the very distal end of the stent protector to avoid dislocation of the stent.

• Brand Name: ORSIRO 2.5/40
• 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: 12127112
• Report Number: 1028232-2021-03825
• Device Sequence Number: 3428126
• Product Code: NIQ
• UDI-Device Identifier: 07640130439429
• UDI-Public: 07640130439429
• Combination Product (Y/N): Y
• 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): 07/06/2021

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: 07/10/2021
• Device Model Number: 391239
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06195514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1