MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER?; STENT, CORONARY, DRUG-ELUTING

Model Number H7493952812250

Device Problem Occlusion Within Device (1423)

Patient Problems ST Segment Elevation (2059); Thrombosis (2100); Vomiting (2144); Discomfort (2330)

Event Date 12/29/2014

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2015-00100.(b)(4) clinical study.It was reported that stent thrombosis occurred.In (b)(6) 2014, clinical assessment indicated that the patient's qualifying condition was stable angina.Subsequently, index procedure was performed.Target lesion #1 was located in the proximal circumflex (lcx) with 70% stenosis and was 18 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation, placement of a 2.5 x 12 mm promus premier drug eluting stent and post-dilatation, with 0% residual stenosis.A second stent was attempted but was not implanted.Target lesion #2 was located in the distal circumflex with 80% stenosis and was 30 mm long with a reference vessel diameter of 2.5 mm.It was treated with pre-dilatation, placement of a 2.5 x 12 mm promus premier stent and post-dilatation, with 0% residual stenosis.A second stent was attempted but was not implanted.Post index procedure, the patient experienced an acute inferior myocardial infarction that was life-threatening requiring medical and surgical intervention; and prolonged hospitalization.Stent thrombosis was noted in the previously placed study stent located in the proximal lcx.In addition, a 10% stenosis in the proximal circumflex was treated with percutaneous coronary intervention (pci), atherectomy and placement of a drug eluting stent, with 0% residual stenosis.Two days post index procedure, the patient was discharged on protocol doses of aspirin and prasugrel.

Manufacturer Narrative

Device is a combination product.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).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that during the index procedure, target lesion #1 was located in the distal circumflex (lcx) which was treated with a 2.5 x 32 promus premier stent and not proximal lcx treated with (2.5 x 12mm promus premier) stent as previously reported.Also, target lesion #2 was located in the proximal lcx which was treated with a 2.5 x 20mm promus premier stent and not distal lcx treated (2.5 x 32mm promus premier⩠stent as previously reported.At the time of event, the patient developed chest discomfort and began vomiting.Patient's electrocardiogram indicated inferoposterior st-segment elevations corresponded to the recently placed stents in lcx.Repeat coronary angiography revealed a thrombotically occluded lcx.The physician performed manual aspiration thrombectomy to restored flow of the vessel.There was a substantial clot burden throughout the vessel and integrilin was administered in the coronary artery and peripherally.Balloon angioplasty was performed throughout the entirety of the previously stented segments followed by deployment of a 2.5 x 12 mm promus premier stent in the proximal lcx at the proximal end of the previously placed stent resulting in 0% residual stenosis.Post procedure, st segment changes on ecg and stent thrombosis were resolved.

• Brand Name: PROMUS PREMIER?
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4441111
• MDR Text Key: 20723243
• Report Number: 2134265-2015-00099
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2016
• Device Model Number: H7493952812250
• Device Catalogue Number: 39528-1225
• Device Lot Number: 17319699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2015
• Initial Date FDA Received: 01/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR