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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
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 of a severely calcified lesion in a moderately tortuous mid cx.During device preparation negative pressure was supplied.Upon delivery, stent became dislodged on calcium shelf and moved downstream.Stent was snared out near sfa.
Additional Manufacturer Narrative
Combination product: yes.Only the stent was returned for investigation and subjected to a technical analysis.The production 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 severely deformed over its entire length.The delivery system was not returned for analysis.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.Based on the conducted investigations, no manufacturing or material related root cause could be determined.Considering the physicians event description, the root cause for the complaint event is most likely related to the handling during the preparations for the intervention (i.E.Application of vacuum before reaching the target lesion).It should be noted that the ifu advises the user to not apply negative pressure to the stent system at any time prior to the placement of the stent across the target lesion.

• 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: 10658311
• Report Number: 1028232-2020-04345
• Device Sequence Number: 2554853
• 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
• Device Implanted Year: 2020
• 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): 09/24/2020

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: 04/03/2021
• Device Model Number: 401739
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03196098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1