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

Catalog Number 1128250-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/25/2019

Event Type  Injury  

Event Description

It was reported that the procedure was to treat an acute myocardial infarction in an unspecified artery.The 2.5x18mm xience proa stent was successfully implanted in 2019, however, the patient fears that she developed an allergic reaction to the material components.The patient already had existing symptoms of me/cfs (myalgic encephalomyelitis/chronic fatigue syndrome) with severe fatigue, pain and neurological symptoms.Despite all the therapies the symptoms worsened significantly after the stent was implanted.It is known that due to a detoxification disorder, high metal levels in the blood were sometimes detectable.There are significant intolerances to various drugs.Recently, frequent extrasystoles and pain have occurred, the cause of which has not really been clarified so far.The patient was in the past allergy tested, but not on the xience stent components and it is well known that the patient has an intolerances to various drugs.No treatment has been provided currently as the physician is unclear if there is a connection between the stent material and the symptoms of the patient.The allergic reaction has not been resolved.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effect of hypersensitivity is listed in the xience alpine/proa everolimus eluting coronary stent systems instructions for use 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.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The xience proa device is currently not commercially available in the us; however, it is similar to a device sold in the us.The udi is unknown because the part/lot number were not provided.

• Brand Name: XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P031); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14880999
• MDR Text Key: 295107880
• Report Number: 2024168-2022-07105
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1128250-18
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other