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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1550300-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Prolapse (2475)
Event Date 09/11/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation as it remains implanted in the patient. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of prolapse is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device. The other devices mentioned are filed under separate medwatch report numbers.
 
Event Description
It was reported that during a right coronary artery stenting procedure, a 3. 0 x 15 mm xience sierra drug-eluting stent was deployed across the distal stenosis at 16 atmospheres. At that time, there was a disruption of the proximal to mid right coronary artery stenosis and the decision was made to cover this area with a drug-eluting stent. A 3. 5 x 28 mm xience sierra was then successfully implanted and post-dilated with a 3. 5x20mm nc trek. After post-dilatation, a perforation was noted. At that time, a 3. 5 x16 mm graftmaster covered stent (9072241) was implanted across the perforation at 20 atmospheres (above rated burse pressure), resolving the perforation; however, the stent was post-dilated with the 3. 5x20mm nc trek and the perforation was noted to continue to leak. Two additional 3. 5x19 graftmaster stents (9112841, 9032941) were implanted, one proximal and one distal to the implanted 3. 5x16mm graftmaster stent, but the perforation continued to leak. An additional xience sierra 3. 5 x 38 mm stent was implanted but the perforation continued to leak. A 2. 8x19mm graftmaster stent (8120641) was advanced, but failed to get distal to the last graftmaster stent and the xience sierra. Another 2. 8x19mm graftmaster stent (9092641) kinked upon insertion into the patient. A 3. 5x19 graftmaster stent (9060541) was advanced, but failed to cross the implanted xience sierra stent. Another 2. 8x19mm graftmaster stent (8120641) was advanced but failed to get distal to the last graftmaster stent and the xience sierra. The patient was taken to surgery where the perforation was treated successfully. There was no reported adverse patient sequela. There was no additional information provided.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10693794
MDR Text Key211859240
Report Number2024168-2020-08677
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/14/2021
Device Model Number1550300-15
Device Catalogue Number1550300-15
Device Lot Number0010741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/16/2020 Patient Sequence Number: 1
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