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

Model Number 10618

Device Problems Device Damaged by Another Device (2915); Activation Failure (3270); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent damage, stent inadequate/insufficient apposition and stent migration occurred.The target lesion was located in the proximal to mid left anterior descending artery (lad) with an aneurysm.After the lesion was dilated, a 3.50 x 16mm synergy ii drug-eluting stent (des) was advanced in the proximal lad 3 to 3.5 mm diameter to distally landing in to a 5.5mm part of the aneurysm.The stent opposed well in the vessel but not able to fully opposed in the distal end in aneurysm; however, it looked okay under cineradiography as deployed in the aneurysm funnel zone (diameter closer to 4mm).A 4.0 non-compliant balloon catheter was used for post dilation; however, the stent deteriorated and moved distally.The physician described the balloon winged and was bulky and got caught on the stent.The stent lengthened and destroyed the integrity/architecture of stent distally.The physician had deliberately tried to flare the distal end of the stent beyond its post dilatation limit of 4.25mm.The vessel appeared lumpy and under stent boost, the stent architecture was compromised along the length of the stent.A 4.00 x 12mm synergy des was successfully deployed within the 3.50 x 16mm synergy des and post dilated with a 5.0 non-compliant balloon catheter to hit the floating struts in the aneurysm.Optical coherence tomography was utilized.The procedure was completed successfully and the patient was discharged and went home the following day with no complications.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8042228
• MDR Text Key: 126270448
• Report Number: 2134265-2018-62579
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2019
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0022161438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• 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