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

Model Number H7493926238250

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.Device is a combination product.(b)(4).

Event Description

It was reported that stent dislodgement occurred.During preparation of a 2.50x38 synergy¿ drug-eluting stent, it was noted that the stent came off the balloon.The procedure was completed using a 2.50x38 non-bsc stent.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was not returned for analysis therefore the catheter batch/serial number could not be identified.A visual examination of the stent found that the stent had detached from the delivery system and was returned partially inside the stent protector.Most damage was on the part of the stent that was not covered by the stent protector.The stent struts were stretched and deformed.The stent protector was returned and the id (inner diameter) was measured and was within specification.Stent detachment most likely occurred due to handling of the device following removal of the stent protector.The sds was not returned for analysis; therefore examination of the balloon as well as individual assessment of the catheter could not be performed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that stent dislodgement occurred.During preparation of a 2.50x38 synergy¿ drug-eluting stent, it was noted that the stent came off the balloon.The procedure was completed using a 2.50x38 non-bsc stent.No patient complications were reported.

• 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: 6195407
• MDR Text Key: 63004148
• Report Number: 2134265-2016-11793
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup
• Report Date: 12/06/2016

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: 09/11/2017
• Device Model Number: H7493926238250
• Device Catalogue Number: 39262-3825
• Device Lot Number: 19063633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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