MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/18; CORONARY DRUG-ELUTING STENT

Model Number	401750
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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.The stent catheter was being introduced and dislodged at the hub of the sheath, right at the exterior point of the sheath.It was noticed that struts were flared.
Additional Manufacturer Narrative
Combination product: yes.The returned product was subjected to a technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation revealed that the stent is not dislodged but displaced from the balloon by about 212 mm in proximal direction on the distal shaft.Stent imprints are visible in the exposed balloon surface, indicating that the stent was initially crimped in between the two radiopaque markers.The stent is deformed at both ends.The balloon has been inflated and was returned in a partly deflated state.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.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 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.It should be noted that the ifu advises to exercise care during advancement through the rotating hemostatic valve adapter and the guiding catheter hub.

• Brand Name: ORSIRO (US) 3.0/18
• 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: 12236392
• Report Number: 1028232-2021-04202
• Device Sequence Number: 3817496
• Product Code: NIQ
• UDI-Device Identifier: 07640130439054
• UDI-Public: 07640130439054
• Combination Product (Y/N): Y
• 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): 07/09/2021

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: 04/28/2022
• Device Model Number: 401750
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 04200676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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