MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION (US) 3.5/30; CORONARY DRUG-ELUTING STENT

Model Number 453965

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2023

Event Type  malfunction  

Event Description

A pk papyrus covered stent system was selected for treatment a moderately calcified lesion in the moderately tortuous part of the mid rca.A guideliner was used during the procedure.The orsiro mission was introduced, but the balloon ruptured during inflation at 8atm.The balloon disengaged with the stent.A snare was used to retrieve the fractured part.

Manufacturer Narrative

Combination product: yes.

Manufacturer Narrative

Combination product: yes.Neither the complaint instrument nor the angiographic material was returned.Therefore, no technical investigation on the subject could be performed.The product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test.In addition, a pressure test of a defined amount of samples is performed by means of manufacturing process output monitoring.Based on the conducted investigations, no material or manufacturing related root cause could be identified.

• Brand Name: ORSIRO MISSION (US) 3.5/30
• Type of Device: 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: 17563660
• MDR Text Key: 321346126
• Report Number: 1028232-2023-04151
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 453965
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01233022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male