MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.75/18; CORONARY DRUG-ELUTING STENT

Model Number	364489
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2021
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 of a mildly calcified lesion (90 percent stenosis degree) in a severely tortuous proximal lcx.The stent dislodged proximal to the lesion and was adapted there to the vessel wall with a balloon.Lot number unknown.
Additional Manufacturer Narrative
Combination product: yes.Initially, no lot number was reported.Therefore, the product release documentation of the last three orsiro 2.75/18 lots that were delivered to the hospital prior to the reported event date were reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The complaint instrument was not returned for analysis.Thus, no technical investigation on the subject could be performed.The angiographic material was provided and reviewed.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The actual complaint event is not visible.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, no manufacturing or material related root cause could be determined.

• Brand Name: ORSIRO 2.75/18
• 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: 12058281
• Report Number: 1028232-2021-03576
• Device Sequence Number: 4421932
• Product Code: NIQ
• UDI-Device Identifier: 07640130439047
• UDI-Public: 7640130439047
• 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): 06/24/2021

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 Model Number: 364489
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1