MAUDE Adverse Event Report: BIOTRONIK AG, BUELACH, SWITZERLAND SYNSIRO 2.5/13; CORONARY DRUG-ELUTING STENT

Model Number 396934

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Event Description

A synsiro drug-eluting stent system was chosen for treatment of the proximal riva.The synsiro was introduced but got stuck inside the guiding catheter and could not be move back and forward.During the attempt to withdrawal it the shaft of the device fractured.

Manufacturer Narrative

Combination product: yes.The returned instrument 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 the reported event.In addition, the angiographic material provided was reviewed.The technical investigation of the returned device revealed that the hypotube has fractured about 62 cm distal to the distal end of the kink protector.At the proximal fragment the hypotube is bent close to the fracture site.Several more small kinks were observed in the hypotube.The cross-section of the hypotube is no longer circular but compressed and the polymer coating is plastically deformed.The findings indicate that the hypotube most probably fractured as a result of significant bending outside of the patients body.Review of the angiographic material did not lead to any further information regarding the nature of the complaint.It shows the complaint instrument and its retrieval, but the actual complaint event is not visible.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process 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 of the device.

Manufacturer Narrative

Combination product: yes.The returned instrument 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 the reported event.In addition, the angiographic material provided was reviewed.The technical investigation of the returned device revealed that the hypotube has fractured about 62 cm distal to the distal end of the kink protector.At the proximal fragment the hypotube is bent close to the fracture site.Several small kinks were observed in the hypotube.The cross-section of the hypotube is no longer circular but compressed and the polymer coating is plastically deformed.The findings indicate that the hypotube was most probably significantly bent outside of the patients body and eventually fractured during the introduction attempt.Moreover, the balloon is not well folded anymore and shows signs of inflation.Stent imprints on the exposed balloon surface indicate that the stent was initially crimped in between the two radiopaque markers.The stent was not returned for analysis.The angiographic material was reviewed and did not lead to any further information regarding the nature of the complaint.It shows the complaint instrument and the retrieval of the shaft fragment, but the actual complaint event is not visible.It can also not be further evaluated when the balloon was inflated and when during the procedure the stent dislodged from the balloon.Review of the production documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.Review of the manufacturing documents for subassembly delivery system and the incoming goods inspection protocols for component hypotube did not reveal any non-conformity.The supplier documents further confirm that all parts have been manufactured and tested as per biotronik vi specifications.During final inspection and inner packaging every device is visually inspected for kinks.As a part of final inspection every stent system also undergoes visual inspection to ensure correct embedding and homogeneous crimping of the stent.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, no manufacturing or material related root cause could be determine.

• Brand Name: SYNSIRO 2.5/13
• 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: 10488836
• MDR Text Key: 205517501
• Report Number: 1028232-2020-03771
• 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,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2022
• Device Model Number: 396934
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 03203170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization