MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 2.75/15; CORONARY DRUG-ELUTING STENT

Model Number 364483

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 08/09/2021

Event Type  Death  

Manufacturer Narrative

Combination product: yes.

Event Description

It was decided to treat a pda stenosis (70-80 percent stenosis degree) with an orsiro stent system.It was attempted to conduct a direct stenting with the orsiro but it would not cross the lesion.Thus the lesion was predilated with 2.0mm balloon but the orsiro was unable to pass through the proximal rca angulation.Very soon the patient became very short of breath and extremely agitated.Thus it was decided to abort the procedure and all of the equipment was pulled out of the patient in one piece.Then it was noticed that the stent was not on the delivery stent system anymore.The patient stabilized post procedure but deteriorated that evening with increasing shortness of breath.He subsequently had a cardiac arrest that he did not survive.The patient was elderly with many co-morbidities.

Manufacturer Narrative

Combination product: yes.Neither the complaint instrument nor the angiographic material was returned for analysis.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 this event.Review of the product release documentation 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.It should be noted that the ifu warns against re-insertion if the orsiro sirolimus eluting coronary stent system was removed prior to expansion.

• Brand Name: ORSIRO 2.75/15
• 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: 12373968
• MDR Text Key: 268350321
• Report Number: 1028232-2021-04804
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2023
• Device Model Number: 364483
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01211092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death