MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 2.25/26; CORONARY DRUG-ELUTING STENT

Model Number	401759
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A severely calcified vessel with moderate tortuosity was pre-dilated with compliant and non-compliant balloons with support from 6f guideliner.It was reported that a considerable amount of force was applied in attempt to cross the lesion.The stent was noted on fluoroscopy to be dislodged from markers and pushed back onto the catheter.The catheter was walked out over the wire where the stent completely dislodged from the catheter into the co-pilot.
Additional Manufacturer Narrative
Combination product: yes the returned product was subjected to a detailed technical analysis and the corresponding product release 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.Microscopic analysis showed stent imprints on the exposed balloon surface, indicating that stent was initially crimped centered on the balloon.The stent was returned separately and is severely deformed over its entire length (i.E.Kinked and several struts are bent).Review of the product release 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 was determined.

• Brand Name: ORSIRO (US) 2.25/26
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 14851812
• Report Number: 1028232-2022-03260
• Device Sequence Number: 20032119
• Product Code: NIQ
• UDI-Device Identifier: 07640130439146
• UDI-Public: 07640130439146
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P170030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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: 09/07/2022
• Device Model Number: 401759
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 08202861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown