MAUDE Adverse Event Report: SYNSIRO 2.5/22; CORONARY DRUG-ELUTING STENT

Model Number 396952

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

Combination product: yes.

Event Description

A synsiro drug-eluting stent system was selected for treatment.During dilatation of the device no pressure could be built up.On angiographic film it was detected that contrast medium was leaking out of the balloon.The delivery system with the balloon was removed and subsequently the stent was dilated with another balloon.

Manufacturer Narrative

Combination product: yes.The returned product was subjected to a detailed technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.In the as returned state the balloon was slightly unfolded and showed signs of an inflation attempt.During functional testing the balloon did not open and water was found leaking from the distal balloon portion.Microscopic inspection of the balloon surface revealed a small longitudinal tear in the distal balloon shoulder.Scratches were observed in close vicinity of the tear.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a helium leak test and a pressure test.The instrument was delivered in a leak-proof condition.Based on the conducted investigations, no manufacturing or material related root cause could be determined.

• Brand Name: SYNSIRO 2.5/22
• Type of Device: CORONARY DRUG-ELUTING STENT
• MDR Report Key: 12548053
• MDR Text Key: 273822294
• Report Number: 1028232-2021-05394
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 396952
• Device Catalogue Number: SEE MODEL NO.
• Device Lot Number: 05212597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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