MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 4.0/13; CORONARY DRUG-ELUTING STENT

Model Number	364480
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro drug eluting stent system was selected for use.During the attempt to cross the calcified lesion in the rca the orsiro could not pass and was therefore removed.Upon removal a stent deformation at the distal end was detected.
Additional Manufacturer Narrative
Neither the complaint instrument nor the angiographic material was provided 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 specifi-cations and passed all inprocess and final inspections.Based on the conducted investigations no manufacturing related root cause could be determined.The final root cause is most likely related to external factors during the procedure.It should be noted that according to the ifu pre-dilatation is mandatory.

• Brand Name: ORSIRO 4.0/13
• 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: 9131995
• Report Number: 1028232-2019-04254
• Device Sequence Number: 14220645
• Product Code: NIQ
• UDI-Device Identifier: 07640130438958
• UDI-Public: 07640130438958
• Combination Product (Y/N): N
• 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): 09/27/2019

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: 07/25/2020
• Device Model Number: 364480
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 07180623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1