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

Model Number 10617

Device Problems Difficult or Delayed Positioning (1157); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported that stent partial deployment occurred.Vascular access was obtained via right femoral artery.The 95% stenosed, 4.5mm x 10mm, de novo target lesion was located in the mildly tortuous and mildly calcified right coronary artery.Following pre-dilation with 3.50x15 and 3.50x13 non-boston scientific balloons, a 4.00 x 12 mm synergy drug-eluting stent (des) was advanced for treatment.Two to three attempts were made to position the stent at the lesion site.When the stent was in position, the balloon was inflated to six atmospheres but the stent only expanded in the proximal and distal end; the middle did not expand.The stent slipped out of the aorta and dislodged to the axillary and an attempt was made to reposition.The procedure was completed with a 4.00 x 16mm synergy des.No patient complications were reported and the patient was stable.The patient will return for an x-ray after three months to see if the 4.00 x 12 mm stent remained stable or if it had migrated.

Manufacturer Narrative

The synergy ous mr 4.00 x 12 stent delivery system was returned for analysis.The stent was not returned with the delivery device.As a result, it was not possible to measure the outer diameter (od) of the crimped in accordance with device specification.A review was performed into the manufacturing stent crimp data for this batch.The crimped stent od was measured at the time of manufacture within maximum stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Evidence of the stent crimp was visible on the balloon.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no kink or damages.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.The device was soaked overnight in a water bath in order to facilitate inflation.A 0.014 test guidewire was inserted through the wire lumen with no resistance noted.An encore inflation unit was used to inflate the device to its rated burst pressure with no issues noted.A vacuum was pulled and the balloon deflated fully in approximately 6 seconds.

Event Description

It was reported that stent partial deployment occurred.Vascular access was obtained via right femoral artery.The 95% stenosed, 4.5mm x 10mm, de novo target lesion was located in the mildly tortuous and mildly calcified right coronary artery.Following pre-dilation with 3.50x15 and 3.50x13 non-boston scientific balloons, a 4.00 x 12 mm synergy drug-eluting stent (des) was advanced for treatment.Two to three attempts were made to position the stent at the lesion site.When the stent was in position, the balloon was inflated to six atmospheres but the stent only expanded in the proximal and distal end; the middle did not expand.The stent slipped out of the aorta and dislodged to the axillary and an attempt was made to reposition.The procedure was completed with a 4.00 x 16mm synergy des.No patient complications were reported and the patient was stable.The patient will return for an x-ray after three months to see if the 4.00 x 12 mm stent remained stable or if it had migrated.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12858044
• MDR Text Key: 281203153
• Report Number: 2134265-2021-14712
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: 10617
• Device Catalogue Number: 10617
• Device Lot Number: 0027217278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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
• Treatment: GUIDE CATHETER: LAUNCHER JR 3.5/6FR; GUIDE CATHETER: LAUNCHER JR 3.5/6FR; GUIDEWIRE: RUNTHROUGH NS EXTRA FLOPPY 0.014; GUIDEWIRE: RUNTHROUGH NS EXTRA FLOPPY 0.014
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 83 KG