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

Model Number H7493926220250

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that balloon removal difficulties were encountered and stent migration occurred.The target lesion was located in the descending artery.A 2.50 x 20 synergy¿ drug-eluting stent was deployed to treat the lesion.Following deflation of the stent delivery balloon and upon its removal, it was noted that the stent delivery balloon was stuck to the stent.The stent then migrated to the brachial artery.Subsequently, another 2.50 x 20 synergy¿ drug-eluting stent was deployed in the descending artery target lesion and a non-medicated stent was deployed over the migrated stent in the brachial artery to avoid further migration.The procedure was completed.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the synergy ous mr 2.50 x 20 mm stent delivery system was returned for analysis.The stent was not returned for analysis as it was deployed at the brachial artery in the patient¿s body.The balloon cones were reviewed and the balloon wings were relaxed.The balloon appeared not fully deflated, most likely due to balloon withdrawal from patient¿s body before complete deflation.During analysis, a vacuum was pulled using an inflation device and the balloon appeared flattened than the returned condition.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination found multiple hypotube kinks along several locations of 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 the inner lumen and mid-shaft section found that shaft polymer extrusion was twisted and stretched distally for a length of 14 mm from the port exchange site.A recommended 0.014" guidewire was loaded from the tip and there was restriction at the port site entry due to the damage on the extrusion shaft.The type of damage noted is consistent with excessive force being applied to the delivery system.The bi-component bond and the proximal weld 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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon removal difficulties were encountered and stent migration occurred.The target lesion was located in the descending artery.A 2.50 x 20 synergy drug-eluting stent was deployed to treat the lesion.Following deflation of the stent delivery balloon and upon its removal, it was noted that the stent delivery balloon was stuck to the stent.The stent then migrated to the brachial artery.Subsequently, another 2.50 x 20 synergy drug-eluting stent was deployed in the descending artery target lesion and a non-medicated stent was deployed over the migrated stent in the brachial artery to avoid further migration.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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7634887
• MDR Text Key: 112225197
• Report Number: 2134265-2018-05644
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: H7493926220250
• Device Catalogue Number: 39262-2025
• Device Lot Number: 0021668795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• 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: 81 YR