MAUDE Adverse Event Report: BOSTON SCIENTIFIC SYNERGY STENT; SYNERGY 3.5 X 16MM

Lot Number 19174128

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/17/2016

Event Type  Injury  

Event Description

Cabg (rima to lima), foreign body extraction.The pt presented with a myocardial infarction.He underwent cardiac catheterization with percutaneous intervention to his rca.The lesion was predilated with a 2.5 x 12 mm pre dilation balloon.A 3.5 x 16 mm synergy drug-eluting stent was placed at the lesion and deployed.Next, the proximal portion of the rca was stented overlapping the first stent with a 3.5 x 8 mm synergy drug-eluting stent.Distal and overlapping to the 3.5 x 16 mm stent, a 3.0 x 8 mm synergy drug-eluting stent was deployed.The stents were postulated with a 3.5 mm noncompliant balloon followed by a 4.0 mm noncompliant balloon.Angiography showed the stents appeared to be well-expanded with no evidence of dissections and timi 3 flow throughout the coronary artery.Next, the guidewire was attempted to be removed for final angiography under fluoroscopy.At this point, after initial withdrawal of the guidewire, the very distal portion of the radiopaque tip of the guidewire appeared to get stuck under the distal edge of the most distal stent (synergy 3.0x 8mm).The stent accordioned back into the second stent (synergy 3.5 x 16 mm) and the distal tip of the guidewire appeared to be lodged within the stent and unable to be removed.Next, release of this wire was attempted using rx 1.5 mm balloon.The wire would not release.Finally, the distal tip of the wire did break and the wire was able to be removed.Unfortunately, there was a retained portion of the wire tip within the accordioned rca stent.The case was able to be completed.F/u cardiac cta showed a longer than expected wire attached to the stent going into the right axillary.Several days later, the pt underwent cabg and the removal of stent and wire.

• Brand Name: SYNERGY STENT
• Type of Device: SYNERGY 3.5 X 16MM
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6078579
• MDR Text Key: 59348408
• Report Number: MW5065811
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 19174128
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 102