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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1074300-12
Device Problems Detachment Of Device Component (1104); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 11/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). 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 the procedure to treat a mildly calcified lesion in the proximal left main (lm) coronary artery, a 3. 0x12 rx xience xpedition drug-eluting stent (des) system was prepped outside of patient anatomy and was advanced to the lesion without difficulty. When deploying the stent, via inflation to 22 atmospheres, the stent was successfully deployed, but the balloon ruptured. The ruptured balloon was rapidly retracted without any difficulty and, upon withdrawal from the anatomy, it was noted that a part of the balloon was missing; it is suspected that the balloon had become caught on the implanted stent during the rapid withdrawal. An attempt was made to snare the missing balloon piece, but the attempt was unsuccessful. A 3. 5x12 xience xpedition stent was deployed over the previous stent, successfully entrapping the balloon piece. There were no adverse patient sequelae and no occurrence of a clinically significant delay. The patient was discharged with no issues or pain. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: the device was returned for analysis. Visual inspections were performed on the returned device. The balloon rupture and separation were confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. It should be noted the xience xpedition, xience xpedition sv, and xience xpedition ll everolimus eluting coronary stent system instructions for use (ifu) states: do not exceed rbp as indicated on product label. Balloon pressures should be monitored during inflation. Use of pressures higher than specified on product label may result in a ruptured balloon with possible intimal damage and dissection. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand NameXIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6227283
MDR Text Key64011731
Report Number2024168-2017-00139
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
Device Catalogue Number1074300-12
Device Lot Number6060241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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: 01/05/2017 Patient Sequence Number: 1
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