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 H7493926020400

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2017

Event Type  Injury  

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 med watch will be filed.(b)(4).

Event Description

It was reported that stent dislodgment occurred.During a transcatheter aortic valve replacement (tavr) procedure, it was noted that the left main artery was at risk for occlusion; therefore, a 4.00 x 20 synergy ii drug-eluting stent was positioned in the left main artery as a protective measure.After the tavr valve was deployed, it was determined that the stent was no longer needed and removal of the synergy ii stent was attempted.However, during removal, the stent was stripped off and remained in the aortic root and left main artery.Subsequently, the dislodged stent was retrieved with a snare back into the non-bsc guide catheter.No patient complications were reported and the patient's condition was stable.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was reported that stent migration and explant occurred instead of stent dislodgment as previously reported.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) was not returned for analysis therefore the catheter batch/serial number cannot be identified.A visual examination of the crimped stent found that the stent had detached from the sds and was severely damaged the whole length with stent struts stretched and distorted.The sds was not returned for analysis therefore reviews for 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 operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that stent migration and explant occurred instead of stent dislodgment as previously 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: 6397555
• MDR Text Key: 69733334
• Report Number: 2134265-2017-02170
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: (01)08714729840190(17)20170920(10)19767153
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2017
• Device Model Number: H7493926020400
• Device Catalogue Number: 39260-2040
• Device Lot Number: 19767153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2017; 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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
• Treatment: EBU GUIDE CATHETER
• Patient Outcome(s): Required Intervention