MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EXPRESS RENAL SD; STENT, RENAL

Model Number UNK673

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Thrombosis (2100)

Event Type  Injury  

Event Description

It was reported via a journal article that stent thrombosis occurred.The patient underwent percutaneous placement of a 5.0x16mm express sd renal stent at 16atm in the left renal artery.The patient's hospital stay was uncomplicated and the patient was discharged on aspirin and clopidogrel.Four weeks post procedure arterial pressure was successfully controlled and creatinine levels were 1.1 mg/dl.Clopidogrel was stopped.Two months later acute left side flank pain developed and nsaid was prescribed and aspirin was stopped to avoid bleeding complications.Three days later, with an increase of pain, the patient was referred to the emergency department.Flank pain was persisting and arterial pressure was 200/110 mmhg and ecg showed sinus rhythm without arrhythmias or myocardial infarction.Ct scan was performed and a vascular exclusion of the left kidney with a stop of contrast in the body of the previously implanted renal stent.Angiography showed a stent thrombosis and manual aspiration was performed.Balloon angioplasty was also performed to ensure better stent expansion with an excellent angiographic result.The patient's blood pressure and creatine levels improved.The patient was discharged on four weeks of antiplatelet therapy with aspirin for life.

Manufacturer Narrative

Literature citation: summaria, f.Et al.(2014)."primary" percutaneous transluminal renal angioplasty for late stent thrombosis.Cardiovascular intervention and therapy 29:283-287.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).

• Brand Name: EXPRESS RENAL SD
• Type of Device: STENT, RENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4393747
• MDR Text Key: 5121572
• Report Number: 2134265-2014-08264
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 43 YR