MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/35; CORONARY DRUG-ELUTING STENT

Model Number	391018
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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 pre-dilated lesion (75 percent stenosis degree) in the rca.After stent implantation it was noticed that the deflation time was longer than usual (more than 15 seconds, normally 10 seconds).
Additional Manufacturer Narrative
Combination product: yes the returned instrument was subjected to a technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The inflation device used in the intervention was returned and identified as a medtronic everest 30.The technical investigation revealed that the balloon has been inflated and was deflated in the as-returned state.A small amount of contrast medium residue was observed in the balloon- and inflation lumen.The balloon could be inflated and deflated within the specified maximum deflation time with the returned inflation device medtronic everest 30.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the reported event is most likely related to the handling during the procedure (i.E.Insufficient deflation time).It should be noted that the ifu advises the user that the instrument shall be deflated for at least 35 seconds.

• Brand Name: ORSIRO 3.5/35
• 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: 11633475
• Report Number: 1028232-2021-01661
• Device Sequence Number: 14413872
• Product Code: NIQ
• UDI-Device Identifier: 07640130439399
• UDI-Public: 07640130439399
• 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): 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: 04/17/2022
• Device Model Number: 391018
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03204787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1