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

Model Number H7493926220220

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/24/2016

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent dislodgement occurred.Vascular access was obtained via the femoral artery.The totally occluded, concentric target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery to the first diagonal artery.After pre-dilation was done, stent implantation was performed in the lad.Then a 2.25x20 synergy¿ drug-eluting stent was advanced and resistance was felt while trying to cross the previously placed stent and the lesion in the first diagonal artery.The stent was stripped off from the stent delivery system balloon.The stent was presumed to be in the lad.Post-dilation with a balloon catheter and "crushing" was performed in an effort to secure the stent.The procedure was completed with a different device.The patient was given the maximum dose of anticoagulation medication and remained under observation.No patient complications were reported and the patient¿s status was stable.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the stent could not be located after it dislodged.The physician only presumes that the stent was crushed into the artery wall with another stent.There was no attempt to snare or retrieve the stent as it could not be seen.Final angiogram results were excellent.

• 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: 6182762
• MDR Text Key: 62670707
• Report Number: 2134265-2016-11511
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2017
• Device Model Number: H7493926220220
• Device Catalogue Number: 39262-2022
• Device Lot Number: 0019439222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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