MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493919315350

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

Patient Problem Vasoconstriction (2126)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Same case as mdr id 2134265-2018-00187, 2134265-2018-00188, 2134265-2017-12742, and 2134265-2017-12746.It was reported that vessel recoil occurred.The chronic totally occluded lesion was located in the mid right coronary artery (rca).After a 6f non-bsc guide catheter and 3 non-bsc guide wires crossed the lesion, three emerge balloon catheters (2.00x15mm, 3.00 x 15mm and 3.50 x 15mm) were used for pre-dilatation of the distal to proximal portion of the vessel.A 3.00 x 38mm non-bsc stent was deployed in the distal rca after some resistance was encountered.A 4.00 x 48mm synergy¿ drug-eluting stent was advanced to the mid to distal rca but there was resistance when crossing the bend and the device failed to cross the lesion.After multiple attempts, the physician decided to remove the device but the stent dislodged in the radial artery.The physician slowly massaged the arm and removed the stent using a pair of forceps.The physician switched to vascular access via the femoral artery and it was noted that the rca was totally occluded again.A non-bsc guide wire crossed the lesion and pre-dilatation was performed with the 3.50 x 15mm emerge balloon and a 4.50 x 10mm non-bsc balloon.A 4.00 x 38mm synergy¿ drug-eluting stent was advanced but delivery to the mid to distal section of the vessel failed.After multiple attempts, the whole system was disengaged from the vessel.The vessel was reengaged and it was noted that the rca was occluded again.A non-bsc guide wire crossed the lesion and pre-dilatation was performed using the 3.50 x 15mm emerge balloon and a 5.00 x 15mm non-bsc 5.00 x 15 balloon.A 4.00 x 28mm synergy¿ drug-eluting stent was advanced but still failed to cross the lesion.The whole system was disengaged from the vessel after multiple attempts.When the system was re-engaged, it was noted that the vessel has recoiled.The physician decided to only stent the short culprit lesion using a short stent.A 3.50 x 16 synergy¿ drug-eluting stent was advanced but it still could not be delivered and when the device was removed, it was noted that the strut has deformed.The procedure was completed with a 3.50 x 18 non-bsc stent which was aided by a guidezilla guide extension catheter.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Upn- search corrected from unk731 - emerge - cmc - (b)(4) (intervent cardio) - 30000 to h7493919315350 - fg emerge mr, ous 3.50mm x 15mm - 39193-1535.Upn corrected from unk731 to h7493919315350.Catalog/model #, device lot number, device expiration date, complainant country, and device manufactured date updated.(b)(4).

Event Description

Same case as mdr id 2134265-2018-00187, 2134265-2018-00188, 2134265-2017-12742, and 2134265-2017-12746.It was reported that vessel recoil occurred.The chronic totally occluded lesion was located in the mid right coronary artery (rca).After a 6f non-bsc guide catheter and 3 non-bsc guide wires crossed the lesion, three emerge balloon catheters (2.00x15mm, 3.00 x 15mm and 3.50 x 15mm) were used for pre-dilatation of the distal to proximal portion of the vessel.A 3.00 x 38mm non-bsc stent was deployed in the distal rca after some resistance was encountered.A 4.00 x 48mm synergy¿ drug-eluting stent was advanced to the mid to distal rca but there was resistance when crossing the bend and the device failed to cross the lesion.After multiple attempts, the physician decided to remove the device but the stent dislodged in the radial artery.The physician slowly massaged the arm and removed the stent using a pair of forceps.The physician switched to vascular access via the femoral artery and it was noted that the rca was totally occluded again.A non-bsc guide wire crossed the lesion and pre-dilatation was performed with the 3.50 x 15mm emerge balloon and a 4.50 x 10mm non-bsc balloon.A 4.00 x 38mm synergy¿ drug-eluting stent was advanced but delivery to the mid to distal section of the vessel failed.After multiple attempts, the whole system was disengaged from the vessel.The vessel was reengaged and it was noted that the rca was occluded again.A non-bsc guide wire crossed the lesion and pre-dilatation was performed using the 3.50 x 15mm emerge balloon and a 5.00 x 15mm non-bsc 5.00 x 15 balloon.A 4.00 x 28mm synergy¿ drug-eluting stent was advanced but still failed to cross the lesion.The whole system was disengaged from the vessel after multiple attempts.When the system was re-engaged, it was noted that the vessel has recoiled.The physician decided to only stent the short culprit lesion using a short stent.A 3.50 x 16 synergy¿ drug-eluting stent was advanced but it still could not be delivered and when the device was removed, it was noted that the strut has deformed.The procedure was completed with a 3.50 x 18 non-bsc stent which was aided by a guidezilla guide extension catheter.No further patient complications were reported and the patient's status was stable.

• Brand Name: EMERGE¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7174483
• MDR Text Key: 96700803
• Report Number: 2134265-2018-00189
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K113220
• 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: 12/11/2017

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: 03/16/2020
• Device Model Number: H7493919315350
• Device Catalogue Number: 39193-1535
• Device Lot Number: 20911230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 02/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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
• Treatment: GUIDE CATHETER: AL1.0 6F; GUIDE WIRE: CORSAIR/ FIELDER F/ GAIA 2ND
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR