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

Model Number H7493926216350

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the balloon was pierced.A 3.50 x 16 synergy¿ drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent was impossible to deploy as the balloon would not inflate and seemed to be pierced.The device was removed and there were no patient complications reported in relation to this event.

Manufacturer Narrative

Device evaluated by mfr: stent delivery system (sds) was returned for analysis.The stent was detached from the delivery system and not returned for analysis.The tip was visually and microscopically examined and no damage was noted.The balloon cones were reviewed and no issues were noted.The balloon wings appeared tightly wrapped and evenly folded and were not subjected to positive pressure.Stent crimp markings were present on the balloon body indicating the stent was crimped to the balloon prior to shipping.An attempt was made to inflate the balloon using an encore inflation device to rated burst pressure.However inflation failed due to a longitudinal tear on the shaft polymer extrusion.Encore inflation device was verified before and after use.A visual and tactile examination of the device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft section found a longitudinal tear on the shaft polymer extrusion 30mm in length starting at the port bond.No other issues were identified during the product analysis.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 the balloon was pierced.A 3.50 x 16 synergy drug-eluting stent was advanced to treat the lesion.However, it was noted that the stent was impossible to deploy as the balloon would not inflate and seemed to be pierced.The device was removed and there were no patient complications reported in relation to this event.

• 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: 6110253
• MDR Text Key: 60288443
• Report Number: 2134265-2016-10105
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 10/21/2016

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: 11/26/2017
• Device Model Number: H7493926216350
• Device Catalogue Number: 39262-1635
• Device Lot Number: 19354477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2016
• 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