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

Model Number H7493926238220

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).

Event Description

It was reported that stent dislodgement occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified first diagonal branch.A 2.25 x 38 synergy¿ stent was advanced; however it was noted that the stent was not mounted on the device.It was uncertain whether it was not there from the beginning or it was dislodged at some point.Fluoroscopy was performed but no stent was noted inside the patient's body.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery catheter (sds) was returned for analysis.The stent was not returned for analysis; however a review of the manufacturing data for the crimped stent profile was performed.The maximum crimped stent profile at the time of manufacture was measured and is within the specification.The manufacturing data confirms that the stent was crimped to the delivery system prior to shipping.As per post carton component verification, the sealed foil pouch is weighed and if the unit is not within weight tolerance, it is reweighed to a maximum of 2 additional times; if it fails it would be assigned for rework.This weight verification control acts to identify such issues as a device with no stent attached to the balloon.There were two stent protectors that were returned for analysis and it cannot be confirmed which one of the two was protecting the stent for the complaint device.The stent protector inner diameters were measured.Both measurements are within the specified stent protector inner diameter.It can be determined that the stent protector was not too tight on the crimped stent provided the correct removal of the stent protector was used.Based on the specified stent protector profile and the recorded crimped stent profile, there is no issues to note with the interaction between the two components.Stent detachment most likely occurred due to handling of the device.The bumper tip of the device showed no signs of damage.The balloon body was reviewed and no issues were noted with the overall balloon.The returned device showed evident of presence of medium inside the inner/outer lumen and the balloon wings appeared relaxed which was evident that the balloon was subjected to positive pressure.Crimped stent markings were visible on the balloon wall.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion.The bi-component bond showed no signs of damage or strain.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 dislodgement occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified first diagonal branch.A 2.25 x 38 synergy¿ stent was advanced; however it was noted that the stent was not mounted on the device.It was uncertain whether it was not there from the beginning or it was dislodged at some point.Fluoroscopy was performed but no stent was noted inside the patient's body.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6191140
• MDR Text Key: 62910307
• Report Number: 2134265-2016-11955
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: H7493926238220
• Device Catalogue Number: 39262-3822
• Device Lot Number: 0019238278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2016
• 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