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 H7493926016250

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

  device is a combination product.(b)(4).  device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that catheter removal difficulties were encountered and shaft break occurred.The target lesion was located in the left internal mammary to left anterior descending (lad) artery.A 2.50x16mm synergy ii drug-eluting stent was properly and correctly deployed in the target lesion.The physician re-advanced the device to post dilate the stent using its balloon to make the sure that the stent was perfectly placed in the lesion.When the physician pulled the stent delivery system (sds), it got caught with the wire (part of the stent).The sds was removed but the distal portion of the shaft was left inside the patient's body.A snaring device was then used to remove the detached portion of the shaft.The implanted stent was fine.The procedure was completed.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr, device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: a synergy ii, us, mr, 2.5 x 16 mm stent delivery system (sds) proximal end including the manifold was returned for analysis, the distal section from the distal end of the port weld to the tip was not returned.The stent was deployed during the procedure.A visual and tactile examination found an extrusion break 6-7 mm distal of port site.The port weld section appeared to be slit from the beginning to the end of the port weld section returned.The bi-component bond showed no signs of damage or strain.A visual and tactile examination of the device found severe hypotube kinks along the full catheter length.The hypotube tab was pulled proximally from its original position (beginning of the port weld) for a distance of 9 mm.Dried medium resembling blood was evident in the manifold.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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that catheter removal difficulties were encountered and shaft break occurred.The target lesion was located in the left internal mammary to left anterior descending (lad) artery.A 2.50 x 16 mm synergy ii drug-eluting stent was properly and correctly deployed in the target lesion.The physician re-advanced the device to post dilate the stent using its balloon to make the sure that the stent was perfectly placed in the lesion.When the physician pulled the stent delivery system (sds), it got caught with the wire (part of the stent).The sds was removed but the distal portion of the shaft was left inside the patient's body.A snaring device was then used to remove the detached portion of the shaft.The implanted stent was fine.The procedure was completed.No patient complications were reported and the patient's status was fine.

• 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: 6269545
• MDR Text Key: 65504509
• Report Number: 2134265-2017-00105
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: (01)08714729840091(17)20170422(10)0019212036
• 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
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2017
• Device Model Number: H7493926016250
• Device Catalogue Number: 39260-1625
• Device Lot Number: 0019212036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR