MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO MISSION 2.5/22 CORONARY DRUG-ELUTING STENT

Model Number 419126

Device Problem Material Deformation (2976)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

An orsiro mission drug-eluting stent system was selected for treatment. When opening the sterile pouch, it was detected that a stent strut was damaged. The device was not used.

Manufacturer Narrative

The complaint instrument was not 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. As a part of final inspection every stent system undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent. Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: ORSIRO MISSION 2.5/22
• 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: 13122157
• MDR Text Key: 283175426
• Report Number: 1028232-2021-06988
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 419126
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05215018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial