MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.25/13; CORONARY DRUG-ELUTING STENT

Model Number 364475

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 01/15/2020

Event Type  Death  

Event Description

An orsiro drug-eluting stent system was selected to treat a severely calcified lesion (70-90 percent stenosis degree) in the distal cx.There are several significant severely calcified lesions in the proximal and mid cx as well as in the left main.The first lesion in the left main could not be crossed with the device.The stent dislodged and an unsuccessful attempt was made to retrieve the stent with a balloon.The stent was adapted to the vessel wall.During the procedure the patient was hemodynamically unstable and passed away on the table.A statement was given by the physician that the event of death is not device related.

Manufacturer Narrative

The complaint instrument was not returned to biotronik.Therefore, no technical investigation on the subject could be performed.The corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In addition, the angiographic material provided was reviewed.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.The images show a dislodged stent between the distal end of the guiding catheter and the target lesion, but the actual complaint event is not visible.Review of the production documentation for the product detailed above verified that the instrument was manufactured according to specifications and fulfilled all the requirements of in-process and final inspection.During final inspection, every stent system undergoes visual inspection to ensure correct stent 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 of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: ORSIRO 2.25/13
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG, BUELACH, SWITZERLAND; ackerstrasse 6; buelach CH-81 80; CH CH-8180
• MDR Report Key: 9638759
• MDR Text Key: 176647846
• Report Number: 1028232-2020-00449
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P170030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: 364475
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01194950
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death