MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.5/40; CORONARY DRUG-ELUTING STENT

Model Number	391239
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
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.The lesion could not be crossed with the device and the shaft of the delivery system became deformed while trying to push it through the lesion.The whole device could be removed from patients body without any problems.
Additional Manufacturer Narrative
Combination product: yes the returned instrument 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 the reported event.The technical investigation of the returned device revealed that the hypotube has fractured about 133 mm distal to the kink protector.Kinks were observed close to the fracture sites of both fragments.The crosssections of the hypotube are no longer circular but compressed and the polymer coating is plastically deformed.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of the patients body.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 complaint event is most likely related to the handling of the device.It should be noted that the ifu advises the user not to force the passage if any resistance is felt, and that the procedure should be aborted if the stent system is unable to reach or cross the lesion easily.

• Brand Name: ORSIRO 2.5/40
• 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: 11672069
• Report Number: 1028232-2021-01831
• Device Sequence Number: 3499136
• Product Code: NIQ
• UDI-Device Identifier: 07640130439429
• UDI-Public: 07640130439429
• 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): 04/15/2021

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: 12/01/2022
• Device Model Number: 391239
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11202776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1