MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926016400

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2016

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: 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 stent dislodgment occurred.A 4.00 x 16 synergy ii stent was selected for use.However, during preparation, the stent fell off from the delivery catheter.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the synergy ii us mr 4.00 x 16mm stent delivery system (sds) was returned for analysis.However, the stent was not returned for analysis with the stent delivery system.The maximum crimped stent profile was found to be within specification.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.Crimp markings were evident on the entire length of the balloon wall indicating overall crimp contact between the coated stent and balloon and the presence of highly pronounced crimp pillowing would suggest that the balloon did not receive any significant positive pressure.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the inner and outer polymer extrusion found no issues.The tip was visually examined and no issues were found.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 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 dislodgment occurred.A 4.00 x 16 synergy ii stent was selected for use.However, during preparation, the stent fell off from the delivery catheter.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 6195575
• MDR Text Key: 63081101
• Report Number: 2134265-2016-11921
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: (01)08714729840138(17)20170726(10)19552230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2017
• Device Model Number: H7493926016400
• Device Catalogue Number: 39260-1640
• Device Lot Number: 19552230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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