Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MULTI-LINK CORONARY STENT SYSTEM; CORONARY STENT DELIVERY SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR MULTI-LINK CORONARY STENT SYSTEM; CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1012167-15
Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2019
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Exemption number e2019001.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, heavily calcified mid left anterior descending de novo lesion that was 85% stenosed.A balance middleweight universal ii guide wire (gw) crossed the lesion.Pre-dilatation was performed with (2) 3.0x15mm non-abbott balloons.Then a 3.0x15mm multi-link 8 stent-balloon was advanced and placed at the lesion.The stent-balloon was inflated twice and up to 10 atmospheres.After the stent deployed, the device was deflated and pulled out within the guiding catheter.However, resistance was felt during removal with the guiding catheter.Once the device was outside of the anatomy it was noted that the balloon did not refold back tightly and the diameter was bigger than normal.There was no adverse patient effects and no clinically significant delay in the procedure.
 
Manufacturer Narrative
The device was returned for analysis.The reported deflation problem and defective device oversized balloon were unable to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned device.The reported failure to fold was 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 incidents from this lot.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, heavily calcified mid left anterior descending de novo lesion that was 85% stenosed.A balance middleweight universal ii guide wire (gw) crossed the lesion.Pre-dilatation was performed with (2) 3.0x15mm non-abbott balloons.Then a 3.0x15mm multi-link 8 stent-balloon was advanced and placed at the lesion.The stent-balloon was inflated twice and up to 10 atmospheres.After the stent deployed, the device was deflated and pulled out within the guiding catheter.However, resistance was felt during removal with the guiding catheter.Once the device was outside of the anatomy it was noted that the balloon did not refold back tightly and the diameter was bigger than normal.There was no adverse patient effects and no clinically significant delay in the procedure.12/17/2019: additional information received today states that the balloon deflation took 10-15 minutes.No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MULTI-LINK CORONARY STENT SYSTEM
Type of Device
CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9147430
MDR Text Key171590486
Report Number2024168-2019-12316
Device Sequence Number1
Product Code MAF
Combination Product (y/n)N
PMA/PMN Number
P020047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Catalogue Number1012167-15
Device Lot Number8061941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2019
Date Manufacturer Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BMW UNIVERSAL II
-
-