MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/22; CORONARY DRUG-ELUTING STENT

Model Number 401756

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 01/10/2020

Event Type  Death  

Event Description

After pre-dilatation of a moderate calcified lesion (90 percent stenosis degree) in a mildly tortuous lad an orsiro drug-eluting stent system was selected.The orsiro could not cross the lesion and was removed.The lesion was deflated again and the same device was re-inserted.The orsiro could not cross again.During withdrawal, the stent dislodged and an attempt was made to retrieve the stent with a snare, but unsuccessful.The stent was then adapted to the vessel wall by using different balloon catheters.During the follow-up with the hospital we received the information that the patient passed away.The death was reported as not device related.

Manufacturer Narrative

Neither the complaint instrument nor the angiographic material was returned for analysis.Therefore no technical investigation on the subject could be performed.The production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.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.It should be noted that the ifu warns against re-insertion if the orsiro stent system was removed prior to expansion.

• Brand Name: ORSIRO (US) 3.0/22
• 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: 9639311
• MDR Text Key: 176714838
• Report Number: 1028232-2020-00450
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130439115
• UDI-Public: 07640130439115
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

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: 06/27/2021
• Device Model Number: 401756
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 06191067
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR