MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/26; CORONARY DRUG-ELUTING STENT

Model Number	364508
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The orsiro drug-eluting stent system was chosen for the treatment of a calcified lesion.After pre-dilatation and implanting of two other orsiro stents, the complaint device could not pass the lesion.
Additional Manufacturer Narrative
Combination product: yes.The returned device was subjected to a detailed technical analysis and the corresponding 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 balloon is well folded and shows no signs of inflation.Judging from the x-ray markers the stent is not displaced.The stent does not show any damage or irregularities.The crimped diameter of the stent still complies with the specification.Review of the production documentation of the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be determined.The root cause for the complaint event is most likely related to the patients anatomy (i.E.Previously implanted stent).

• Brand Name: ORSIRO 3.0/26
• 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: 10473351
• Report Number: 1028232-2020-03679
• Device Sequence Number: 3273517
• Product Code: NIQ
• UDI-Device Identifier: 07640130439177
• UDI-Public: 7640130439177
• 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): 08/28/2020

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: 11/04/2021
• Device Model Number: 364508
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 10194619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1