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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ABSORB BIORESORBABLE VASCULAR SCAFFOLD ABSORBABLE CORONARY DRUG - ELUTING STENT

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ABBOTT LABORATORIES ABSORB BIORESORBABLE VASCULAR SCAFFOLD ABSORBABLE CORONARY DRUG - ELUTING STENT Back to Search Results
Device Problems Collapse (1099); Fracture (1260); Migration or Expulsion of Device (1395); Nonstandard Device (1420)
Patient Problems Pulmonary Embolism (1498); Renal Failure (2041); Renal Failure (2041); Respiratory Distress (2045); Respiratory Distress (2045); Urinary Retention (2119); Heart Failure (2206); Heart Failure (2206); Abdominal Distention (2601)
Event Date 06/14/2017
Event Type  Injury  
Event Description
(b)(6) placed abbott dissolving stent in my husband, (b)(6) without our permission or knowledge prior to. We have attempted to find out health insurance company, (b)(6) approved this prior to. However, after raising concerns about this (b)(6) has begun to further ignore my husband's life threatening issues. My husband was hospitalized twice immediately following the placement of this stent; his health has declined significantly since. In (b)(6) 2017, (b)(6) started to experience a dry, persistent cough. From (b)(6) 2017-(b)(6) 2017 and (b)(6) 2017-(b)(6) 2017, (b)(6) was admitted to the hospital in heart and kidney failure. Most significant is that (b)(6) is a heart transplant recipient. (b)(6) had not experienced a raise in his creatine level until immediately following the left catheterization on (b)(6) 2017, during which the surgeon discovered the stent had shifted and collapsed. We have raised our concerns about the use of this stent on a heart transplant recipient with (b)(6) and (b)(6) since (b)(6) and (b)(6) 2017.
 
Event Description
Add'l info received on 05/29/2018 from reporter for #mw5077019. We are (b)(6) members (for over 20 yrs) and my husband is a 17 yr heart transplant recipient. (b)(6) has contracted (b)(6) for (b)(6) pre/post transplant care. On (b)(6) 2017, cardiologist, dr (b)(6) at (b)(6) placed an abbott absorb (bvs) sent in my husband's heart without our consent. My husband's health has seriously declined since. (b)(6) has experienced all the adverse symptoms documented in studies regarding these specific stents. The abbott absorb stent had been recalled 3 months prior to the placement in my husband. In (b)(6) 2017, (b)(6) started to experience a cough. Afer seeing his (b)(6) primary care physician in (b)(6) 2017, he was prescribed otc allergy medication. After a week long hospital stay ((b)(6) 2017) (b)(6) saw a (b)(6) pulmonary specialist who didn't perform a vq scan. In (b)(6) 2017, (b)(6) was diagnosed by (b)(6) pulmonary specialist with two pulmonary embolisms. On (b)(6) 2017, my husband had a f/u left catheterization. Dr (b)(6) placed a xience stent over the absorb stent which had "collapsed, shifted and fractured. " dr (b)(6) discharged my husband severely bloated from water retention, starting he had iv hydrated (b)(6) to "protect his kidneys from contrast and (b)(6) would urinate the water off by being active. (b)(6) was in kidney failure immediately after the (b)(6) 2017 catheterization and dr (b)(6) never documented his symptoms following the catheterization. On (b)(6) 2017, (b)(6) post transplant coord with (b)(6), (b)(6) told us (b)(6) was being considered for re-heart transplant. In (b)(6) 2017 during a 3 wk hospitalization at (b)(6), his transplant team told us (b)(6) would need a heart and kidney transplant. (b)(6) was given 5 stents over a 10 month period, (b)(6) 2017. He has not had a left catheterization or another stent placed since (b)(6) 2017. When we have asked why, (b)(6) and (b)(6) drs have told us that they (now) want to protect his kidneys, as though this wasn't an option before. Again, it was never an option given to us. The left catheterization was performed until they resulted in kidney failure. My husband is now in heart and kidney failure. While (b)(6) has apologized and sighted a "miscommunication", my husband's health is being seriously neglected by (b)(6). It is important to note (specifically due (b)(6) is a heart transplant recipient) (b)(6) had no symptoms of a blockage prior to any stent being placed. No one ever offered (b)(6) alternative treatment. When (b)(6) first stent was placed in (b)(6) 2016 he went in to (b)(6) for his annual check up and left catheterization. The only thing were told prior to the first xience being placed at that time is they were going to look for "any blockages. " this was a routine statement that was made prior to each annual catheterization for the past 17 years. We have repeatedly asked why a recalled device was used without our knowledge and consent. We have repeatedly inquired about a plan for care for (b)(6). We have asked why the abbott absorb stent was even determined to be an option for (b)(6), a heart transplant recipient with a history of restenosis. We have not received any answers. We reported our concerns to (b)(6) (b)(6) transplant coord in (b)(6) 2017, and again in (b)(6) 2018, yet, no resolve and continued delays in treatment that have resulted in 3 hospital stays where he was treated for life threatening symptoms; symptoms (b)(6) drs ignored for weeks. (b)(6) removed his coord from (b)(6) care in (b)(6) 2018 and began a "review" of his health care thus far, although the same coord is still doing things to impede (b)(6) treatment. We have documented everything via email, phone calls, videos and photos of my husband and have all (b)(6) medical records. We filed a report with medwatch concerning the use of the absorb stent.
 
Event Description
(b)(6) placed abbott dissolving stent in my husband, (b)(6) without our permission or knowledge prior to. We have attempted to find out health insurance company, (b)(6) approved this prior to. However, after raising concerns about this (b)(6) has begun to further ignore my husband's life threatening issues. My husband was hospitalized twice immediately following the placement of this stent; his health has declined significantly since. In (b)(6) 2017, (b)(6) started to experience a dry, persistent cough. From (b)(6) 2017-(b)(6) 2017 and (b)(6) 2017-(b)(6) 2017, (b)(6) was admitted to the hospital in heart and kidney failure. Most significant is that (b)(6) is a heart transplant recipient. (b)(6) had not experienced a raise in his creatine level until immediately following the left catheterization on (b)(6) 2017, during which the surgeon discovered the stent had shifted and collapsed. We have raised our concerns about the use of this stent on a heart transplant recipient with (b)(6) and (b)(6) since (b)(6) and (b)(6) 2017.
 
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Brand NameABSORB BIORESORBABLE VASCULAR SCAFFOLD
Type of DeviceABSORBABLE CORONARY DRUG - ELUTING STENT
Manufacturer (Section D)
ABBOTT LABORATORIES
MDR Report Key7486267
MDR Text Key107483547
Report NumberMW5077019
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 05/29/2018
2 Devices were Involved in the Event: 1   2  
2 Patients were Involved in the Event: 1   2  
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/03/2018 Patient Sequence Number: 0
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