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

Model Number H7493926238350

Device Problems Occlusion Within Device (1423); Activation, Positioning or Separation Problem (2906)

Patient Problem Thrombosis (2100)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent inadequate expansion and stent thrombosis occurred.In (b)(6) 2017, the patient presented for percutaneous coronary intervention (pci).The 90% stenosed, 60mm in length, de novo target lesion was located in the calcified, 4.5mm in diameter, with 4mm minimum lumen diameter proximal to mid right coronary artery (rca).After a guide wire was inserted, an imaging catheter was advanced, but failed to cross the lesion.After pre-dilation was performed, intravascular ultrasound (ivus) and kissing balloon technique were performed on the bifurcation with rt branch.A 2.50 x 16 synergy¿ drug-eluting stent was then deployed at 16 atmospheres to treat the lesion.However, ivus result revealed that there was a part of incomplete expansion, so post-dilatation was performed.Subsequently, a non-bsc stent was deployed in distal of mid rca with 75% stenosis.It was overlapped about 1-2mm with the synergy stent.Residual stenosis was 0% with timi flow 3.In (b)(6) 2018, suspected stent thrombosis was reported and pci was performed.After a failed attempt to aspirate, balloon expansion was performed and the result was good.The procedure was completed.Residual stenosis was 25% and the patient condition was stable.

Manufacturer Narrative

Describe event or problem updated.Upn- search corrected from h7493926216250 - synergy ous mr 2.50 x 16 - 39262-1625 to h7493926238350 - synergy ous mr 3.50 x 38 - 39262-3835 upn corrected from h7493926216250 to h7493926238350.Catalog/model # corrected from 39262-1625 to 39262-3835.(b)(4).

Event Description

It was further reported that it was a 3.50 x 38 synergy¿ drug-eluting stent that was implanted in proximal to mid right coronary artery and not a 2.50 x 16 synergy¿ as the latter was never been used in the case.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7425814
• MDR Text Key: 105303759
• Report Number: 2134265-2018-02923
• 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
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926238350
• Device Catalogue Number: 39262-3835
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: ONYX; STENT: ONYX
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 57