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

Model Number UNK776

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.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

Same case as mdr id 2134265-2016-03401.It was reported that stent explantation and migration occurred.The target lesion was located in the mid to proximal internal mammary artery (lima).After successful deployment of three synergy drug-eluting stents (des) in the lesion, a 2.50x38 synergy ii des was then advanced to be deployed more distally.However, as the fourth stent entered into the ostial part of the lima, it got caught on the first stent that was previously deployed.When the fourth stent was pulled back, it tore the stent in the ostial part out and caught tissue on it.The two stents then went down in the subclavian artery and were snared.The procedure was completed using another of the same device.No further patient complications were reported and the patient's status was okay.

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: the stent had detached from the balloon and was returned for analysis intertwined with another stent.The stent delivery system (sds) was not returned.A visual examination of the stent found the stent severely damaged across its entire profile with struts distorted, bunched, stretched and crushed.The stent could not be separated from a previously placed stent.Individual assessment of the catheter cannot be performed as the stent delivery system was not returned.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

Same case as mdr id 2134265-2016-03401 it was reported that stent explantation and migration occurred.The target lesion was located in the mid to proximal internal mammary artery (lima).After successful deployment of three synergy drug-eluting stents (des) in the lesion, a 2.50x38 synergy ii des was then advanced to be deployed more distally.However, as the fourth stent entered into the ostial part of the lima, it got caught on the first stent that was previously deployed.When the fourth stent was pulled back, it tore the stent in the ostial part out and caught tissue on it.The two stents then went down in the subclavian artery and were snared.The procedure was completed using another of the same device.No further patient complications were reported and the patient's status was okay.

• 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: 5613555
• MDR Text Key: 43839204
• Report Number: 2134265-2016-03402
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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: 04/04/2016

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 Model Number: UNK776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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