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

Model Number H7493926228270

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).  device evaluated by mfr.: synergy ous mr 2.75 x 28mm returned for analysis; the stent delivery system was not returned for analysis.A damaged stent (severely stretched), was returned caught of the distal end of a non-bsc balloon catheter.Per the hub of this returned catheter (2.75/12), the balloon of this returned catheter was broken into two sections - the returned stent was caught on the distal section of the bunched balloon.A synergy stent delivery catheter was not returned.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

Event Description

Reportable based on device analysis completed on 29jun2018.It was reported that balloon inflation issues occurred.Vascular access was obtained via femoral artery.The 95% stenosed, 28mm x 2.75mm, eccentric, de novo target lesion with a bend of more than 45 degrees and less than 90 degrees was located in the mildly tortuous and mildly calcified coronary artery.A 2.75 x 28 synergy¿ stent was advanced for treatment.However, stent system balloon failed to inflate.The device was removed and the procedure was complete with another 2.75 x 28 synergy¿ stent.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed detached/separated stent and stent damage.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7704281
• MDR Text Key: 114548842
• Report Number: 2134265-2018-06448
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2018
• Device Model Number: H7493926228270
• Device Catalogue Number: 39262-2827
• Device Lot Number: 20580128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• 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