MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT¿ PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493918438300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Death (1802); Pulmonary Edema (2020)

Event Date 09/11/2015

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was reported that the patient death occurred.Patient presented with an inferior wall myocardial infarction (mi).Vascular access was obtained via the right radial artery under local anesthesia.The 90% stenosed, 36mmx3mm, concentric, de novo target lesion contained <=45 degree bend and was located in the moderately tortuous and non-calcified left anterior descending artery (lad).A 6f 3.0 non-bsc guide catheter was placed coaxially and a choice floppy wire was then advanced to cross the lesion.Thrombus aspiration was performed multiple times and the lesion was predilated with a 2x10mm non-bsc balloon catheter.Subsequently, a 3.00x38mm promus element plus drug-eluting stent was advanced and deployed to treat the target lesion.Post dilation was performed with a 3.5x10 non-bsc balloon catheter.The patient was then transferred to the critical care unit (ccu).However, after sometime, the patient developed severe chest pain, pulmonary edema and eventually died in the ccu due to pulmonary edema.

Manufacturer Narrative

Device evaluated by mfr: the stent delivery system (sds) for promus element 28/2.50 was returned instead of promus element plus 38/3.00mm.A visual examination of the crimped stent found no issues with the crimped stent.There were no signs of damage, stretching or lifting of the stent struts.The bumper tip of the device showed no signs of damage.The balloon cone profiles were reviewed and no issues were noted with the overall balloon profile.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found no issues with the hypotube shaft profile.A visual and tactile examination found no issues with the shaft polymer extrusion profile.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

It was reported that the patient death occurred.Patient presented with an inferior wall myocardial infarction (mi).Vascular access was obtained via the right radial artery under local anesthesia.The 90% stenosed, 36mmx3mm, concentric, de novo target lesion contained <=45 degree bend and was located in the moderately tortuous and non-calcified left anterior descending artery (lad).A 6f 3.0 non-bsc guide catheter was placed coaxially and a choice floppy wire was then advanced to cross the lesion.Thrombus aspiration was performed multiple times and the lesion was predilated with a 2x10mm non-bsc balloon catheter.Subsequently, a 3.00x38mm promus element¿ plus drug-eluting stent was advanced and deployed to treat the target lesion.Post dilation was performed with a 3.5x10 non-bsc balloon catheter.The patient was then transferred to the critical care unit (ccu).However, after sometime, the patient developed severe chest pain, pulmonary edema and eventually died in the ccu due to pulmonary edema.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5204438
• MDR Text Key: 30500892
• Report Number: 2134265-2015-07524
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

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: 08/06/2016
• Device Model Number: H7493918438300
• Device Catalogue Number: 39184-3830
• Device Lot Number: 17804034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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): Death
• Patient Age: 58 YR
• Patient Weight: 62