MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND SYNSIRO PRO 2.75/13; CORONARY DRUG-ELUTING STENT

Model Number 419163

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

A synsiro pro drug-eluting stent system was selected for treatment.The delivery balloon of the device could not be inflated and a leakage was detected.

Manufacturer Narrative

The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation showed that the balloon is still folded but shows signs of an inflation attempt.The stent is slightly opened at both ends.The crimped diameter of the stent does not comply anymore with the specification.Microscopic inspection revealed a severe deformation of the inner shaft between the device tip and the distal x-ray marker.The inner shaft has further fractured just distal to the guide wire exit port.Electron- and energy-dispersive x-ray spectroscopy identified residues of teflon and contrast medium inside the inner shaft which likely contributed to the complaint event.Please note that teflon is not a component or used as auxiliary material in the production of synsiro pro.Unfortunately, the guidewire used in the intervention was not returned for analysis.Review of the production 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 detect irregularities such as e.G.Deformations or particles.In addition, every instrument is shipped with a 0.015 inch transportation wire that covers the full guidewire lumen.No difficulties in removing the transportation wire have been reported.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause was determined.

• Brand Name: SYNSIRO PRO 2.75/13
• 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: 15433457
• MDR Text Key: 300075191
• Report Number: 1028232-2022-04773
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 07640130442238
• UDI-Public: (01)07640130442238(17)2312
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: 419163
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 11212299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1