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

Model Number H7493926238300

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).

Event Description

It was reported that balloon deflation difficulty occurred.The target lesion was located in the moderately tortuous mid left anterior descending artery.Following pre-dilation, a 3.00 x 38 synergy¿ drug-eluting stent was deployed at 12 atmospheres to treat the lesion.However, post deployment when deflation was tried to perform, reverse vascular flow was observed and the stent delivery balloon did not deflate.After slight deflation, it was carefully removed from the patient's body and the procedure was completed by post dilation with another balloon.Upon testing the device outside the patient's body, leakage of contrast media was noted near the guidewire exit port.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr.: stent delivery system was returned for analysis.The stent was implanted in the patient and therefore not returned for analysis.The balloon cones were reviewed and no issues were noted.The balloon wings appeared relaxed from their original folded position and appeared to have been subjected to positive pressure and a vacuum pulled.An attempt was made to inflate the device to rated burst pressure; however, the device failed to maintain pressure and began to leak due to a tear along the port bond.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple hypotube kinks along the full length of the catheter.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 a tear along the port bond.The device was loaded on a 0.014¿¿ guidewire without issue.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 & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon deflation difficulty occurred.The target lesion was located in the moderately tortuous mid left anterior descending artery.Following pre-dilation, a 3.00 x 38 synergy drug-eluting stent was deployed at 12 atmospheres to treat the lesion.However, post deployment when deflation was tried to perform, reverse vascular flow was observed and the stent delivery balloon did not deflate.After slight deflation, it was carefully removed from the patient's body and the procedure was completed by post dilation with another balloon.Upon testing the device outside the patient's body, leakage of contrast media was noted near the guidewire exit port.No patient complications were reported and the patient's status was good.

• 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: 7753625
• MDR Text Key: 116224751
• Report Number: 2134265-2018-07055
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2019
• Device Model Number: H7493926238300
• Device Catalogue Number: 39262-3830
• Device Lot Number: 0021852002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• 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