MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND SYNSIRO 3.0/26; CORONARY DRUG-ELUTING STENT

Model Number 396960

Device Problem Structural Problem (2506)

Patient Problem Death (1802)

Event Date 05/26/2020

Event Type  Death  

Event Description

A synsiro drug-eluting stent system was chosen for treatment of a moderately calcified lesion (90 percent stenosis degree) at a trifurcation of the left main.After stent implantation and manipulation with the guide wire, the synsiro stent could not hold the vessel open.After post-dilatation the stent was adapted to the vessel wall by using another stent.During intervention no observable clinical symptoms have occurred.3 days later the patient died.It was stated by the physician that the death was not related to the device.

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.The angiographic material shows the diseased lm.After several predilatations the complaint stent is successfully released and then post dilated.The physician then performs rewiring during which the collapsed complaint stent is visible.A balloon is inflated to open the stent/vessel.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all inprocess and final inspections.Based on the conducted investigations, no manufacturing or material related root cause could be determined.The root cause for the complaint event is most likely related to the handling during the procedure (i.E.Selection of wrong stent size, inflation above rbp, post dilation to more than the maximum expandable diameter).It should be noted that the ifu advises the user to select the stent inner diameter according to the reference vessel diameter of the target lesion, to not exceed the labeled rated burst pressure and to not post dilate the stent to more than the maximum expandable diameter recommended in the table compliance chart.

• Brand Name: SYNSIRO 3.0/26
• 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: 10248464
• MDR Text Key: 198068536
• Report Number: 1028232-2020-02765
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: 396960
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 01204321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death