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

Model Number H7493926228350

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-06726.It was reported that the stent was explanted.The target lesion was located in the severely tortuous and moderately calcified left main (lm) artery extending to the left circumflex (lcx) artery.After pre-dilatation and implantation of a 3.50 x 28 synergy⠄rug-eluting stent in the lm, a 2.50 x 38 synergy drug-eluting stent was advanced to treat the lesion in the lcx.However, during crossing attempts, the stent fell off.The device was removed from the patient and intravenous ultrasound (ivus) was performed to check the previously implanted 3.50 x 28 synergy stent in the lm.It was then noted that the stent also fell off.Subsequently, stenting was re-done with a 3.5x32 stent and the procedure was completed.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the complaint device was returned for analysis.The stent had detached from the balloon and was returned for analysis stuck to another stent and without the stent delivery system (sds).The stents were separated during analysis.A visual examination found one stent bunched at one end and remaining struts distorted and stretched.The second stent was bunched and creased together into an oval shape.As the delivery system was not returned with the stent, therefore individual assessment of the device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable cause of the reported difficulties may be due interaction with another device.(b)(4).

Event Description

It was reported that the stent was explanted.The target lesion was located in the severely tortuous and moderately calcified left main (lm) artery extending to the left circumflex (lcx) artery.After pre-dilatation and implantation of a 3.50 x 28 synergy¿ drug-eluting stent in the lm, a 2.50 x 38 synergy¿ drug-eluting stent was advanced to treat the lesion in the lcx.However, during crossing attempts, the stent fell off.The device was removed from the patient and intravenous ultrasound (ivus) was performed to check the previously implanted 3.50 x 28 synergy¿ stent in the lm.It was then noted that the stent also fell off.Subsequently, stenting was re-done with a 3.5x32 stent and the procedure was completed.No patient complications were reported and the patient's status was stable.

• 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: 5841107
• MDR Text Key: 50963685
• Report Number: 2134265-2016-06775
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2017
• Device Model Number: H7493926228350
• Device Catalogue Number: 39262-2835
• Device Lot Number: 18872028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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: 69 YR