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

Model Number H7493926238300

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Age at time of event: 18 years or older.Device is a combination product.(b)(4).

Event Description

It was reported that fiber was present on the tip of the stent.The 38x3.0mm, de novo target lesion was located in the non calcified vessel.A 3.00 x 38 synergy drug eluting stent was selected for use to treat the lesion.However, during preparation, the nurse noted presence of fiber on the tip of the stent which was further confirmed by the physician.Hence, the stent was abandoned and a new 3.00 x 38 synergy stent was opened to complete the procedure.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found no issues with the profile and no signs of overlapping or raised stent struts.No foreign material was identified across the length of the stent.The bumper tip of the device showed no signs of damage to the tip and no foreign material was identified.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination found no issues with the shaft polymer extrusion profile.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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that fiber was present on the tip of the stent.The 38 x 3.0 mm, de novo target lesion was located in the non calcified vessel.A 3.00 x 38 synergy(tm) drug eluting stent was selected for use to treat the lesion.However, during preparation, the nurse noted presence of fiber on the tip of the stent which was further confirmed by the physician.Hence, the stent was abandoned and a new 3.00 x 38 synergy(tm) stent was opened to complete the procedure.No patient complications were reported and the patient's status was stable.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5256940
• MDR Text Key: 32352613
• Report Number: 2134265-2015-08035
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SG
• 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: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2016
• Device Model Number: H7493926238300
• Device Catalogue Number: 39262-3830
• Device Lot Number: 18037896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2015
• 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