MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10632

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

Patient age: (b)(6).Device is a combination product.Device evaluated by mfr: synergy ous mr 3.50 x 48mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts in the proximal half of the stent were lifted, pulled and bunched in all directions.The undamaged stent outer diameter was measured using snap gauge and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.It was initially reported that the device did not inflate however based on additional information it was reported that there was difficulty advancing.As a result it was decided to complete an inflation/deflation test as per complaint investigations.The device was inflated to its rated burst pressure of 16 atm and then subjected to a negative pressure to ensure full deflation.No issues were noted.A visual and microscopic examination of the bumper tip showed signs of distal tip damage.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid-shaft section found a kink in the lasercut section, 10.0cm proximal of the exchange port.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 04jun2020.It was reported that advancing difficulties were encountered.Vascular access was obtained via femoral artery.The 75% stenosed, 46mm x 3.8mm, concentric, de novo target lesion with a <=45 degree bend was located in the mildly tortuous and non-calcified right coronary artery.After a 0.014 non-bsc guidewire cross the lesion, pre-dilatation was performed with a 3.5x30 non-bsc balloon catheter resulting to 30% residual stenosis.A 6 fr non-bsc guide catheter was advanced together with a 3.50 x 48 synergy drug-eluting stent.However, the stent was stuck and it failed to advance.The device was completely removed and the procedure was completed with a 3.5x38 and a 3.5 x 15 non-bsc stent.No patient complications were reported and the patient was stable.However, returned device analysis revealed a stent damage.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10197015
• MDR Text Key: 196798524
• Report Number: 2134265-2020-07771
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: 10632
• Device Catalogue Number: 10632
• Device Lot Number: 0024534818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 85