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Catalog Number 1012451-15
Device Problems Deflation Problem (1149); Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528)
Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Myocardial Infarction (1969); Renal Failure (2041); Shock (2072); Thrombosis (2100); Respiratory Failure (2484)
Event Date 11/20/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The patient experienced ischemia, but remained hemodynamically stable throughout the procedure and did not experience any electrocardiogram (ecg) changes or any chest pain. Due to the deflation failure, the patient was transferred to the operating room for emergency bypass surgery. The chest was opened, the balloon was punctured with a needle inserted directly through the coronary artery, and the balloon was fluoroscopically observed to deflate inside of the artery. The deflated balloon was then able to be easily withdrawn into the guide catheter, then all catheters and wires were removed via the left femoral artery sheath. The bypass surgery was successfully completed. The patient experienced post-operative bleeding requiring transfusion of blood products, renal failure, disseminated intravascular coagulation (dic) (thrombus), myocardial ischemia and injury (infarction), vasodilatory shock, hepatic failure, and respiratory failure. As of (b)(6) 2016, the patient is stable but still in the intensive care unit; the patient continues to improve but patient status is still tenuous. No additional information was provided. Concomitant medical products: inflation: indeflator stent: 2. 5x28mm xience alpine. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
Event Description
It was reported that during a planned percutaneous coronary intervention on (b)(6) 2016, the patient was started on dual anti-platelet therapy and an unspecified 2. 5x28mm xience stent was sized to the distal portion of a mildly to moderately calcified, 80% stenosed lesion in the proximal to mid left anterior descending (lad) coronary artery, with a plan to post-dilate the proximal end of the stent to optimize expansion in the proximal lesion area. After deployment of the 2. 5x28mm xience stent without issue, intravascular ultrasound showed good apposition but under-expansion of the more proximal portion of the stent. A 3. 5x15 nc trek rx balloon dilatation catheter (bdc) was prepped without issue and easily advanced to the stent to perform the pre-planned post-dilatation. When inflating the nc trek rx, the balloon inflation was unusually slow (longer than 10 seconds to achieve 10 to 12 atmospheres of pressure), but the balloon was ultimately able to be completely inflated. When attempting to deflate the balloon several times, it was unable to be deflated at all and was consequently unable to be withdrawn from the stent. Blood in the indeflator was noted, suggesting rupture in the shaft proximal to the balloon. An attempt was made to puncture the balloon percutaneously using a transit catheter and stiff wires, but the attempt was unsuccessful.
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
Event Description
Subsequent to the initial filed medwatch report, it was reported that the patient was elderly, had presented with chest pain, and was too fragile to undergo surgery and was, thus, alternatively referred for percutaneous coronary intervention. The deployed 2. 5x28 xience stent was subsequently reported to be specifically a 2. 5x28 rx xience alpine stent. As of (b)(6) 2016, the patient remained a high risk patient, but was in stable condition, with slow but continued improvement. However, additional information received on (b)(6) 2017 indicates that the patient expired during the (b)(6) 2017 due to unspecified complications after the surgery. The 3. 5x15 nc trek rx balloon dilatation catheter was received with the hypotube shaft separated and the guide wire exit notch had a tear. Additional information received confirmed that the hypotube shaft was intentionally cut / separated in order to facilitate removal of the device from the artery. No additional information was provided.
Manufacturer Narrative
(b)(4). Evaluation summary: the device returned for analysis. The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath. On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues. Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints. To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on march 17, 2017 [medwatch # 2024168-2017-02310]. Corrective action has been implemented per site operating procedures. The product will continue to be trended. The abbott internal recall number is 2024168-3/14/2017-002-r.
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Manufacturer (Section D)
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
MDR Report Key6175804
MDR Text Key62442024
Report Number2024168-2016-08879
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number1012451-15
Device Lot Number60701G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/15/2016 Patient Sequence Number: 1