MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/40; CORONARY DRUG-ELUTING STENT

Model Number	391020
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Combination product: yes.Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore, no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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.It should be noted that the ifu clearly states that pre-dilatation is mandatory.
Event or Problem Description
An orsiro drug-eluting stent system was selected for treatment of a mildly calcified lesion (99 percent stenosis degree) in moderately tortuous ostial rca.After ivus confirmation was attempt to use the orsiro for direct stenting, but could not cross the lesion.It was tried to pull the orsiro back but it was noted that the stent has been shifted.As the stent was still on the balloon it was inflated at the proximal part of the lesion and the delivery system was removed.After that the orsiro stent was deployed with semi-compliant balloon catheter.

• Brand Name: ORSIRO 3.5/40
• 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: 11631849
• Report Number: 1028232-2021-01662
• Device Sequence Number: 14427903
• Product Code: NIQ
• UDI-Device Identifier: 07640130439450
• UDI-Public: 07640130439450
• 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
• Report Date (Section B): 04/07/2021

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: 04/08/2021
• Device Model Number: 391020
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03194805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1